Federal Judge Concludes that Listing of Dioxin as a "Known" Human Carcinogen is Reasonable
1. SPI, APC, and FPI File Comments on FDA Proposed Rule on Implementation of Food-Contact Notification and Companion Draft Administrative Guidance Document
On September 25th, we submitted, on behalf of the Committee, comments to FDA on its proposed rule on implementation of the Food-Contact Notification (FCN) program and the companion draft administrative guidance document. Our comments focused on four areas where we believe clarification is needed: (1) that the 120-day review period runs from the date of receipt by FDA of the FCN, not from the date of acceptance or acknowledgment of the FCN by FDA (the FCN statute specifies date of receipt as the beginning of the 120-day period, but the proposed rule can be read as starting the period on acceptance of the FCN by FDA); (2) that Form 3480 is intended to provide lists and brief summaries of information contained in the FCN, not to duplicate the full FCN discussion; (3) that Good Laboratory Practices (GLPs), as this term is normally used by the Agency, are required only for toxicology studies, not for migration testing; and (4) that FCNs are required only for food-contact substances that meet the statutory definition of "food additive," and companies are fully entitled to determine for themselves that a substance is not a food additive. For more detailed information on our recommendations, please see a copy of the comments attached to this letter.
The American Plastics Council (APC) and the Foodservice & Packaging Institute (FPI) also submitted comments on the proposed rule for the FCN program. We obtained these comments from the FDA docket, and discuss the comments below. Only SPI, APC, and FPI filed comments in this docket.
We were pleased to note that FPI specifically cited the SPI comments and supported our recommendation that FDA clarify that the 120-day review period will begin to run from receipt of the notification rather than from acceptance by the agency. In addition, FPI recommended, as SPI did, that the program use the "FCN" designation rather than "Pre?Market Notification (PMN)" to avoid confusion with the Environmental Protection Agency's (EPA's) PMN program under the Toxic Substances Control Act (TSCA).
APC likewise discussed in its comments several issues that were raised in SPI's comments. Specifically, APC requested that FDA clarify the Good Laboratory Practice requirement and the fact that notifications are required only for food?contact substances that are food additives. APC also questioned the utility of Form 3480, stating that the form merely summarizes and refers the reviewer back to information contained elsewhere in the notification. As did SPI, APC supported FDA's decision to issue acknowledgment letters, and further recommended that the final rule require FDA to issue confirmation letters indicating that the notification is effective. Finally, APC also commended FDA for extending to notifications the categorical exclusions from the need to file environmental assessments that are applied to petitions.
Despite the fact that APC agreed with SPI's comments on several key points, they provided two additional comments that seem somewhat problematic. First, APC objected to FDA's statement in its Administrative Guidance that "anyone may submit to FDA a notification for a new use of an FCN." According to APC, the legislative history of the Food and Drug Administration Modernization Act indicates that Congress intended to allow only manufacturers and suppliers of food-contact substances the right to submit notifications under this program. In fact, APC's comments imply that only the manufacturer of a substance should be allowed to file a notification.
Actually, as we are in a position to know from our role in drafting the FCN legislation with FDA and shepherding the bill through Congress, there was no intent to limit who could file a notification. As you know, under the food additive petition process, anyone has been able to file a petition; the FCN process likewise is intended to be open to anyone interested in seeking clearance for food-contact substances. We particularly are concerned that APC's comments suggest that non-manufacturer suppliers should be prevented from submitting notifications. We already have filed notifications on behalf of companies to allow their use of substances manufactured by other companies, and we know that APC's comments on this issue are contrary to the interests of some in the plastics and other packaging industries. Based on our experience with FDA in drafting this legislation, we do not expect the Agency to adopt APC's suggestion, but we cannot be certain; nor can we predict possible consequences for particular notifications.
APC also made a comment regarding the transferability of FCNs. We agree that FCNs must be transferable in the event of corporate reorganizations, such as mergers, acquisitions, and restructuring. However, in our experience, FDA already has adequate and simple procedures to address such transfers. One merely files a letter changing the name of the notifying party, with written confirmation of the change in corporate control.
Beyond the simple issue of a change in the ownership or name of a notifying party, APC goes further to suggest that FDA should allow notifiers to license, sell, or otherwise transfer the rights granted under the FCN program to others. At a minimum, this would require FDA to create a procedure ensuring that the Agency is informed of all transfers and licenses and receives assurance that terms of the notifications will be observed. The additional complications of such a procedure seems of questionable value when any company can file its own notification and have it become effective in 120 days. Subsequent notifications also can rely substantially on data submitted with prior notifications.
Finally, we are troubled by APC's suggestion in the context of transferability that an FCN is a "private license" for a particular manufacturer. This may play into an existing tendency among some at FDA to treat the FCN system as "licensing" a particular manufacturing process, leading to demands for unnecessary data and suggestions that all aspects of the process must remain exactly as described in the notification, possibly restricting industry in making minor manufacturing changes.
2. GAO Report Says FDA and USDA Need to Improve Their Recall Programs; Sen. Harkin Seeks Mandatory Recall Authority for FDA
On September 15th, the General Accounting Office (GAO) released a report recommending that USDA and FDA improve their recall programs. The report was prepared at the request of Sen. Tom Harkin (D-IA), the ranking minority member on the Senate Agriculture Committee, who sought confirmation of his view that USDA and FDA need mandatory recall authority. The GAO collected information on the number of food recalls documented by the agencies in the last 15 years and how many of those recalls were associated with foodborne illness. The GAO also attempted to document the extent to which the companies delayed initiating the recall, but found that, although the agencies track information on their own recall activities, they do not maintain data on companies' activities to ensure that the recalls are initiated and carried out without delay.
In light of its findings, the GAO recommended that FDA and USDA provide specific timelines to industry for carrying out food recalls that involve potentially serious adverse health risks, including procedures to expeditiously notify their distribution chains and the public. The GAO further recommended that the agencies improve their recall tracking systems to include information on the timeliness of companies' recall activities.
Although the GAO report stopped short of recommending mandatory recall authority for USDA or FDA, Sen. Harkin is reportedly planning legislation to provide FDA with mandatory recall authority. The legislation, expected to be introduced early in the next Congress, will likely be similar to the Safer Meat and Poultry Act (S 18) that was introduced by Sen. Harkin in 1999. That statute would give USDA mandatory recall authority and allow the agency to require recalls and impose civil monetary penalties on companies that violate food safety regulations. The legislation also would require food plants, companies and distributors to notify USDA if they believe their products are contaminated.
Legislation drafted by Rep. Dennis Kucinich (D-Ohio) would allow FDA to temporarily seize adulterated food products, clearing the way for the government to act quickly to take products off the market. With the exception of infant formula, FDA currently cannot order a food recall, and must request that a company conduct a recall. If a company refuses to institute a recall, FDA must obtain a court order to seize the product.
In a related news item, The House of Raeford Farms, Inc., of Raeford, N.C., initially refused to comply with a USDA request to recall food that tested positive for contamination with a pathogenic microorganism. The meat had tested positive for Listeria monocytogenes in a government test. This is reported to be the first instance of a company declining a USDA request for a recall when there has been a positive pathogen finding in a government test. Instead of instituting a recall, the company initially told its distributors to hold the product while additional testing was conducted. Three additional samples of the meat subsequently tested negative by a private laboratory. In the absence of an initial recall by the company, USDA warned consumers and distributors about its findings, and detained or otherwise controlled all of the product believed to be affected. Ultimately, the company cooperated in the recall, but its initial reluctance, whether justified or not, already has been cited as support for mandatory recall authority for FDA and USDA
3. EPA Proposes Adding Diisononyl Phthalate to its List of Toxic Chemicals Subject to Reporting under EPCRA
The Environmental Protection Agency (EPA) is proposing adding diisononyl phthalate (DINP), a plasticizer that has been used in manufacture of polyvinyl chloride, to its list of toxic chemicals subject to the reporting requirements under EPCRA (42 U.S.C. § 11023). The proposed rule was published in the Federal Register on September 5, 2000 (65 Fed. Reg. 53681). As you may know, EPCRA requires certain facilities that manufacture, process, or otherwise use listed chemicals in amounts above reporting threshold levels to report their environmental releases and other waste management quantities of such chemicals annually.
The proposal is a result of a petition brought by the Washington Toxics Coalition (WTC), which alleges that DINP exposure causes cancer, other systemic toxicity, developmental toxicity and endocrine disruption. WTC claims that DINP is "used as the principal plasticizer in toys and many other products used by children" and, further, that "in every study conducted to measure DINP exposure from children's use of plastic, DINP has been shown to migrate from the plastic into saliva when the plastic object is chewed or put into the child's mouth." EPA reviewed available data in response to the petition and concluded that the substance can reasonably be anticipated to cause cancer and liver, kidney, and developmental toxicity. Based on this conclusion, EPA preliminarily determined that there is sufficient evidence for listing DINP under EPCRA.
You may recall that last year, at the request of the Consumer Product Safety Commission, manufacturers voluntarily removed DINP from plastic toys intended for children under three years of age and products intended to go into children's mouths. However, EPA has determined that this voluntary action has had little impact on the demand for DINP, since DINP is used in other types of toys and in other products.
4. FDA Announces Steps to Accelerate Review of Direct Food and Color Additives
Dr. Alan Rulis, the Director of the Office of Premarket Approval (OPA) in the Center for Food Safety and Applied Nutrition (CFSAN) at FDA, has announced several initiatives designed to speed up review of direct food and color additive petitions. These initiatives were described in an October 5th "Dear Colleague" letter.
The first of the specific initiatives involves OPA's plans to grant to petitioners, at their request, a "post-filing technical update meeting" any time after 120 days have elapsed since the date a petition was filed. During this meeting, CFSAN review scientists assigned to the petition will be available to provide the petitioner with a synopsis of the state of the petition review at that point in time, along with a summary of principal issues the review team will be focusing on during the course of its review.
Dr. Rulis also announced that FDA soon will be publishing in the Federal Register an announcement of availability of two draft documents intended to provide guidance for petitions regarding the preparation of regulatory submissions in electronic format to OPA. The documents will be entitled "Draft Guidance for Industry - Providing Regulatory Submissions in Electronic Format, General Considerations;" and "Draft Guidance for Industry - Providing Regulatory Submissions in Electronic Format for Food Additive and Color Additive Petitions." OPA's emphasis on electronic filing is part of the so-called "FARM (food additive regulatory management) Project," which is a comprehensive plan to improve the efficiency and functioning of the petition review program in CFSAN.
Other initiatives aimed at improving the efficiency of the review process include OPA's plans to hire approximately 50 new employees, a considerable proportion of which will be devoted to work on direct food and color additive petitions. To accommodate the new employees, OPA already has acquired additional office space. Finally, the Agency has awarded a contract to ICF (a consulting firm) for the extramural review and evaluation of data packages submitted to FDA. This contract will serve as a "bridge" until CFSAN can complete the hiring and training of new FDA scientists.
5. FDA and FSIS to Jointly Review Petitions Involving Direct Additives, Including Irradiation, for Meat and Poultry Products
Beginning August 25th, FDA and the Food Safety and Inspection Service (FSIS) of the USDA will provide concurrent review of all petitions seeking approval to use a food ingredient or source of radiation in or on meat or poultry products. The final rule providing for this simultaneous review was published in the Federal Register on August 25, 2000 (65 Fed. Reg. 51758). Prior to this rule becoming effective, FSIS did not begin their review until after FDA formally approved the additive, delaying the approval process. Note that the rule applies to direct additives only, and has no effect on packaging materials. As you may recall from our previous reports, USDA does not have its own clearance process for packaging materials. Supplier assurances of FDA compliance are sufficient at this time to establish USDA compliance as well.
6. GAO Report Says Studies Show Food Irradiation Benefits Outweigh Risks
A recent GAO report states that scientific studies conducted during the past 50 years indicate that the benefits of food irradiation outweigh the risks. The report discusses some of the risks that have been typically attributed to food irradiation, explains why those risks are minimal, and concludes that food irradiation is a safe, effective tool for reducing foodborne pathogens. Within approved dosages, irradiation has been shown to destroy at least 99.9% of common foodborne pathogens such as Salmonella, Campylobacter jejuni, E. coli O157:H7, and Listeria monocytogenes. In addition, food irradiation can extend the shelf life of many fruits and vegetables by reducing spoilage bacteria and mold.
Despite these findings, only a small fraction of the total amount of food consumed in the United States is irradiated annually. The GAO report states that a major reason for the limited use of food irradiation is questionable consumer acceptance of irradiated foods.
Some consumer advocacy groups are actively opposing the use of irradiation to protect food safety. One such group, Public Citizen, issued a report October 3rd alleging that FDA does not have adequate data to support the safety of food irradiation. Public Citizen also recommends that all food irradiation permits be revoked, and calls for a full congressional investigation into FDA's regulation of irradiated food.
Meanwhile, the USDA's Agricultural Research Service (ARS) and Ion Beam Applications (IBA), a manufacturer of irradiation systems, have teamed up to study irradiation and food safety. Under the agreement, ARS will use IBA's commercial sterilization and ionization facilities to compare the effectiveness of gamma, electron beam and x-ray sources in controlling food-borne pathogens. They also will examine how these treatments affect the properties of food such as taste and texture, and how to optimize the benefits of the process
7. Congress Directs FDA to Report on Status of Irradiation Labeling and to Finalize Regulations by March 2002
Congress is putting pressure on FDA to finalize its regulations on irradiation labeling which were mandated by the FDA Modernization Act (FDAMA). By November 15, 2000, FDA was supposed to report to the House and Senate Committees on Appropriations on the status of the labeling of irradiated foods. As of November 20, 2000, the Committees had not received the report, and FDA was seeking an extension of the deadline. Congress also has added language to the conference report accompanying the fiscal year 2001 agriculture appropriations bill directing FDA to finalize the regulations by March 1, 2002. The FDAMA conference report had directed the Agency to implement new regulations by November 1998, but FDA waited until February 18, 1999 to issue an advanced notice of proposed rulemaking (ANPR) requesting ideas on labeling revisions. To date, FDA has not followed up with a proposed regulation.
8. SPI Successfully Pushes Truth in Regulating Bill through Congress
On October 17, 2000, President Clinton signed into law the "Truth in Regulating Act of 2000" (S. 1198), which will allow certain members of Congress to ask the GAO to review any proposed or final rule that has an annual economic impact of more than $100 million. SPI played a major part in drafting the legislation and lobbying Congress for its passage. Specifically, a chairman or ranking member of a committee of either House of Congress with legislative or oversight jurisdiction relating to the action may ask the GAO to conduct a substantive evaluation of the agency's data, methodology, and assumptions used in developing the rule.
9. EC Releases Working Document on BADGE, BFDGE and NOGE
As you may be aware from prior reports, several European Union (EU) member countries have raised concerns about the chemicals bisphenol-A diglycidyl ether (BADGE) and bisphenol-F diglycidyl ether (BFDGE), which have important uses in can coatings. During this Committee's meeting last December, the Inter-Industry Group reported that Switzerland had instituted a ban on all can coatings containing BFDGE and BADGE. Now, the European Commission (EC) has released a working document concerning BADGE, BFDGE and novolac glycidyl ether (NOGE).
Specifically, the directive would allow for the use of the substances until December 31, 2004, subject to certain limitations on their use. With respect to BADGE, BFDGE, and their derivatives, the permissible sum of the migration levels in foodstuffs or in food simulants would not exceed 1 mg/kg, or the permissible amount of the substances present in finished materials and articles would not exceed 1 mg/6 dm2. There would be no limit on NOGE until December 1, 2002, at which time the quantity of NOGE components with more than two aromatic rings and at least one epoxy group, as well as its derivatives containing chlorohydrin functions and having a molecular mass less than 1000 Daltons, would not be permitted to be detectable in the finished materials and articles with a limit of detection of 0.2 mg/6 dm2.
10. Federal Judge Concludes that Listing of Dioxin as a "Known" Human Carcinogen is Reasonable
In previous letters we have reported that a group of restaurateurs is suing the National Toxicology Program (NTP) and the Department of Health and Human Servies (HHS) for an injunction to prevent dioxin from being listed as a known human carcinogen in NTP's Ninth Report on Carcinogens. The previous listing classified dioxin as a suspected carcinogen. At issue are the criteria NTP used to support the reclassification.
On September 30th, U.S. District Judge Emmet G. Sullivan ruled that NTP's upgrading of dioxin to "known to be a human carcinogen" was reasonable, clearing the way for NTP to publish an addendum to the Report upgrading the designation of dioxin. In the wake of the plaintiffs motion for injunction pending appeal, however, NTP announced that it will not take action while the motion is pending.
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As always, if you have any questions on the above, or if we can be of assistance in any other way, please do not hesitate to contact me, Jerry Heckman or Deborah Ziffer.
Cordially yours,
Ralph A. Simmons
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