| Comment Record|
Mr. Christopher Guay ||
2002-08-30 15:40:28 |
Procter & Gamble |
| Comments for FDA General |
1. General Comments
August 30, 2002
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20852
RE: Docket Number 02N-0276
Public Health Security and Bioterrorism Preparedness and Response Act of 2002
Section 305: Registration of Food Facilities
Request for Public Input
Dear Sir or Madam:
Submitted herewith in duplicate are The Procter & Gamble Company's comments in response to FDA’s July 17, 2002 request for public input prior to the development of new regulations required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (“Act”). The Procter & Gamble Company (“P&G”) is an international consumer product company headquartered in Cincinnati, Ohio that markets consumer products in over 160 countries around the globe. P&G markets products in the US regulated by FDA (food, cosmetics, over the counter (“OTC”) drugs, medical devices, dietary supplements, animal foods, and Rx drugs) as well as products regulated by other Federal agencies (laundry detergents, paper towels, and cleaning products).
On June 12, 2002, the President signed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 into law. This law requires FDA to promulgate new regulations in several sections within 18 months or the law will take effect automatically. P&G strongly endorses FDA’s objective to finalize the required regulations within this timeframe. Without final regulations, we believe implementation of the Act could be highly disruptive not only to the US food supply but to US nonfood consumer product manufacturing and distribution systems. We also appreciate the Agency’s willingness to seek early input on regulation development and we submit the following comments in the spirit of this cooperative endeavor.
1. Ingredients Should be Regulated by Intent
Sections 301 through 315 of the Public Health Security and Bioterrorism Preparedness and Response Act should be applied only to food and ingredients intended for use in food. Ingredients intended for use in anything other than food (cosmetics, laundry detergent, OTC drugs, medical devices, etc.) should not be regulated under these Sections once the intent to use them for non-food uses has been established. This is clearly consistent with Congressional intent to protect the food supply.
This issue is of particular importance because ingredients commonly used in food products are also used as components and ingredients in non-food products. In fact, foods, cosmetics, OTC drugs, laundry detergents, and other consumer product formulations contain many of the same ingredients. For example, both a food and non-food product may contain a common colorant (an FD&C Dye), sweetener (saccharin), preservative (sodium benzoate), buffer (calcium phosphate), chelator (citric acid), emulsifier (PEG), flavor (mint), solubilizer (propylene glycol), thickener (carrageenan) and/or humectant (sorbitol). There are alternate ingredients for each functional class cited above that are used in foods and nonfoods alike in the US. The vast majority of nonfood consumer products marketed in the US contain ingredients also found in food products, including the most common of all, water. Because these individual components or ingredients are “food” in some instances and “non-food”, in others, FDA should create a system or mechanism to determine the importer/manufacturer/distributor’s intended use of the each item in the context of the Act before regulating an item under the Act. Without distinguishing the status of common ingredients based on intended use, companies that import and/or use versatile ingredients automatically would be forced to follow the registration, notice, recordkeeping and other requirements. Importantly, many non-food businesses using versatile ingredients believe they are exempt from these provisions of the Act and are not represented in these proceedings to date. Moreover, it would likely strain FDA resources to try to enforce the Act in this manner. We recommend a simple statement by the importer/manufacturer/distributor should suffice to determine which ingredients are “foods” subject to the Act. For example, if we purchase food grade citric acid for shipment to a detergent facility for use entirely for laundry detergent, registration of this facility and recordkeeping per the Act should not be required.
A primary factor distinguishing factor between drugs, devices, cosmetics and foods is product intent as indicated in the following definitions in the Federal Food, Drug and Cosmetic Act:
§201(f), defines “food” to be “Articles used for food or drink for man or other animals, 2) chewing gum, and 3) articles used for components of any such article.”
§201(g) defines “drug” to be “Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals, and articles (other than food) intended to affect the structure or any function of the body of man or other animals and articles intended for use as a component of any articles specified [above]”.
§201(h) defines “device” to be “an instrument, apparatus, implement, machine, contrivance, implant, in vitro agent, or other similar or related article, including any component, part, or accessory…..intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals”
§201(i) defines “cosmetic” to be “Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance and articles intended for use as a component of any such articles.”
Importantly, these definitions also cover the components of these products. The ingredients of a drug product are regulated as drugs. The ingredients of a cosmetic are regulated as a cosmetic. The components of a food are regulated as a food.
Since the product lines of many US companies, including P&G, encompass both food products and nonfood products that use common ingredients, the new legislation appears to require us to distinguish when a common ingredient is and is not a food. We believe the best approach to determine what items should and should not be regulated under the Act is to require the responsible parties to declare their intended use of articles to FDA upon distributing or importing. For example, a common food ingredient such as sodium saccharin would be regulated as a food if the facility declared it would be used in foods. If saccharin were declared for use only in cosmetics, however, it would not be subject to the Act.
2. Definition of Facility
The construction of the Act requires clarity of the definition for facility in order to efficiently implement the Act’s registration and record keeping (Section 306) requirements. The definition of facility is critical because transfers of products between “facilities” are subject to the record keeping requirements the Act. While on the surface, this may seem to be a minor issue, from a practical implementation standpoint the definition has far-reaching implications and directly impacts the complexity of complying with the Act. Without FDA regulations further defining a “facility”, each truck, each railcar, each building, each refrigeration unit, each storage container, each temporary holding locale or device could be classified as a facility.
In addition, the definition of facility in the Act is ambiguous. A “facility” could be defined as a single building, a group of buildings having a single site address, a group of adjacent buildings with multiple site addresses associated with the same operation, a number of specific buildings on a larger site that are associated with the same operation or owner, or a number of other permutations including buildings, sites, addresses, owners, etc. as the basis for definition and distinction. The problem becomes apparent when companies ask the following questions: Is an on-site warehouse a different facility from the manufacturing building located 30 feet away? Is an on-site raw material warehouse a different facility from the on-site finished product warehouse? Is the railcar that moves raw material from a site warehouse to the manufacturing building a facility?
We believe the only practical definition of “facility” is for facility to mean “a fixed, enclosed structure or structures controlled by a single owner, operator or agent at a single location.” Given that there are so many types of operations, we believe companies need to be allowed to define a facility in the way that makes the most sense for each given operation and site configuration. It could be a single building, two or more buildings on a site, or two or more buildings in close proximity related by product or function. It could be owned and/or rented space. We believe that industry and the Agency are both best served by taking this approach. If not, companies could be forced to register the same locations (and the transportation devices located within) as different facilities, which would make the tracing and protection mechanisms required in the Act more difficult for FDA.
3. Exclude Transportation Vessels/Vehicles From the Definition of Facility
We recommend that the definition of facility specifically exclude transportation vehicles, vessels and containers. This exclusion would cover trucks, railroad cars, shipping containers, airplanes, boats, and other modes used to transport food products and food ingredients between fixed enclosed structures. This is consistent with the exemption provided fishing vessels without processing capability onboard.
Most shipments of food ingredients or food products are shipped from a seller to a buyer or are shipped intracompany from one location to another. In both cases, transportation between locations is usually contracted to someone else, a shipping company, an individual with a truck or a delivery service. Requiring each shipping firm, each delivery service and each individual who transports a food between two fixed sites to register as a “facility” would be a very onerous requirement for individuals and would be impractical for larger firms since most product they transport never comes onto their premises. Despite the additional increase in cost, resulting slow-downs in supply chain, and confusion amongst the shippers, we see no obvious benefit beyond what the Act already requires of food companies in Section 306. Similarly, requiring each railroad car, each airplane, each boat cargo, each shipping container, or each tractor-trailer to register as a separate facility appears to provide no meaningful benefit, yet would be cumbersome to implement and extremely complex to keep updated for purposes of the Act.
Given that we see no obvious benefit in registering transportation companies or transportation vehicles, vessels, and containers as facilities under §305 that furthers the purposes of the Act, plus the additional complexity and limitations associated with trying to include them, we recommend they be excluded.
4. Disposition of Food Previously Held by an Unregistered Facility
The Public Health Security and Bioterrorism Preparedness and Response Act makes it a prohibited act to fail to register a food facility in accordance with Section 415 of the FD&C Act. This could mean that an entity acquiring/using/distributing food shipped previously from an unregistered facility (that was required to be registered under the Act) cannot use that food even if the downstream entity was unaware that a previous facility was unregistered and was properly complying with all provisions of the Act. While companies will make all reasonable efforts to ensure its suppliers comply with this provision, it is highly likely that a company downstream in the distributing network will learn an upstream facility, perhaps an African miller without computers or electricity, was not registered. Alternatively, FDA itself may learn directly of facility that wasn’t previously registered that should be registered, but could punish later “innocent” users of food articles seizing or destroying materials acquired from the unregistered facility.
When a company or FDA learns that a food product has been stored, prepared, packaged, or held at a facility that is not registered with FDA, what happens to that facility, food products in that facility, and to foods subsequently processed using that food product? Will a violation be automatically considered a “threat of serious adverse health consequences or death to humans or animals”? Will an FDA investigation be required? Will it be viewed as an administrative violation? Will FDA assist facilities in getting registered? Will FDA permit companies that find an unregistered facility to help that facility register?
We believe that there must be a provision in the regulations to help register unregistered facilities with minimal disruption to the food distribution network. The food distribution system in the US is delicate and currently doesn’t have excess inventories to cover frequent disruptions, outages and shortages that could be caused by FDA detentions and seizures. In short, a mechanism is needed to get the facility registered quickly and to minimize destroying, quarantining, or recalling downstream food products for the sole reason that they passed through an unregistered facility. Possible remedies include simply using the standard registration process, adding additional fields for registration under these circumstances, conducting site visits, and penalties.
5. De Minimus Exclusion for Sampling at Foreign Facilities
The Act specifies that each domestic facility engaged in manufacturing, processing, packing, or holding food is required to register. For foreign facilities, the requirement is different; only the last facility located outside the US where food is processed or packaged is required to register. This means that unregistered foreign facilities can subsequently hold or store product prior to export to the US without having to be registered. In some cases, these unregistered facilities may inspect or sample product. Sampling may be for qualitative attributes such as identity, size, condition, defects, or ripeness, which may be used to determine order of shipment, price, or storage time.
We believe sampling should be recognized as a de minimus activity. Sampling is not a manufacturing, processing, or packing operation and can help provide assurance of product quality by validating certain product attribute(s) prior to shipment. In fact, sampling is more akin to de minimus activities such as labeling that are already exempted under the Act. Designating sampling as de minimus requires foreign sites that actually process or package foods and do not merely sample/test foods already manufactured, processed, or packaged to register. In addition, foreign facilities conducting de minimus activities (hold product, ship product, inspect product) as defined by the Act should not be prohibited from registering, since some may gain competitive advantages by registering.
As FDA develops a system for registering facilities engaged in manufacturing, processing, packing, or holding food for consumption, we encourage the Agency to develop a system that minimizes duplication, allows real time registrations, allows maximum flexibility to accommodate the numerous variations in facility design and function, and does not unnecessarily disrupt the flow of product in distribution.
The Procter & Gamble Company appreciates the opportunity to comment on this new rule and I would be happy to discuss any of these comments in more detail. I can be contacted at (513) 983-0530 or firstname.lastname@example.org.
THE PROCTER & GAMBLE COMPANY
North American External Relations
Christopher B. Guay
Legislative and Regulatory Affairs