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 November 13, 2001
(202) 434-4120 The Society of the Plastics Industry, Inc. Food, Drug, and Cosmetic Packaging Materials Committee Dear Ladies and Gentlemen: In this letter, we discuss recently proposed food safety legislation designed to prevent instances of bioterrorism, including the most recent incarnation of a bill seeking to create a new single food safety agency in place of the current regulatory scheme. We also report on what apparently is a new policy at the Food and Drug Administration (FDA) requiring a two-week turn around time for responses to questions on Food-Contact Notifications (FCNs), or the Agency will restart the 120 day review period from the date of the submission of the new information. In addition, we discuss the recent anthrax scare at FDA that closed its mailrooms and the status of the program allowing for electronic submissions of FCNs that would provide an alternative to the use of mail should future scares occur. Finally, we discuss the status of the FCN at FDA that would allow the use ethylene/vinyl acetate/vinyl alcohol during irradiation of food; the response of consumer groups and industry to FDA's safety assessment on di-(2-ethylhexyl)phthalate (DEHP) in polyvinyl chloride medical devices; a final rule prohibiting use of biocides in organic food that may apply to food packaging; proposed new regulation in the European Union (EU) that would serve as the basis for developing a policy on the use of polymeric additives in the EU; and other matters of interest to the Committee. Table of Contents
1. Food Safety Bills Proposed to Combat Bioterrorism The September 11th terrorist attacks have again brought to the forefront concerns about the safety of the nation's food supply and renewed calls in Congress for the creation of a single food safety agency and FDA mandatory food-recall authority. Recently proposed legislation also would provide FDA with increased authority over imported food. A bill introduced by Sen. Hillary Rodham Clinton (D-N.Y.) would provide FDA with the authority to recall and detain immediately any contaminated food. In addition, Clinton's "Protecting the Food Supply from Bioterrorism Act" (S. 1551) would allow FDA to inspect food processing facilities overseas to ensure that they meet U.S. safety standards; currently, FDA can only conduct inspections once food is at U.S. borders. The bill also calls for additional funding to improve testing and surveillance technology to allow inspectors to identify food pathogens more quickly. A House bill, the "Imported Food Safety Act of 2001" (H.R. 3075), would give FDA authority over imported food, including fresh fruits and vegetables, that is similar to the authority the U.S. Department of Agriculture (USDA) has for imported meat and poultry. The bill proposes a user fee for imported foods, and allocates the projected $56 million per year that would be generated by these user fees for use in funding increased border inspections and research and development of tests for detection of microbial and pesticide contamination. The bill also mandates country-of-origin labeling for imported foods subject to FDA regulation, and establishes severe criminal penalties for the international adulteration of food. Finally, the most recent incarnation of a bill seeking to create an independent, single food safety agency in place of the current regulatory scheme was introduced in early October by Sen. Richard Durbin (D-Ill.). At a hearing October 10th before a Senate Governmental Affairs subcommittee, government and industry representatives weighed in on the Safe Food Act of 2001 (S.1501). A similar bill, introduced May 1st by Rep. Rosa DeLauro (D-Conn.), is pending in the House. According to Sen. Durbin, the current food safety system is "fragmented" by the involvement of 12 different federal agencies executing 35 different laws. A report recently issued by the General Accounting Office concurs with Durbin's assessment. Testifying at the hearing, Robert A. Robinson, managing director of Natural Resources and Environment at GAO, said that food safety problems persist, "largely because food safety responsibilities are still divided among several agencies that continue to operate under different regulatory approaches." Robinson cited a 1998 report issued by the National Academy of Sciences (NAS), which found that "there are inconsistent, uneven, and at times archaic food statutes that inhibit use of science-based decision-making in activities related to food safety, and these statutes can be inconsistently interpreted and enforced among agencies." Tim Hammonds, president and CEO of the Food Marketing Institute, lent measured support to Durbin's proposal. Hammonds said that the designation of a single food safety agency has become imperative, but emphasized that "we are on record in support of designating a single food agency, not in support of creating an entirely new agency." According to Hammonds, "too much expertise would be lost, too much of our existing credibility would be squandered, and too much time would be wasted if we attempt to create an entirely new agency from scratch." Instead, Hammonds suggested centralizing resources, responsibility, and authority within one of the existing agencies, and then elevating "the status of this group to a level appropriate to our new challenges." Health Secretary Tommy Thompson is on record opposing Durbin's measure to create a new bureaucracy, pointing out that FDA, if given adequate funding, has the expertise to oversee food safety. Similarly, Bernard Schwetz, acting principal deputy commissioner of the FDA, withheld his support for Durbin's single-agency approach, although he did acknowledge that FDA should be granted the requisite statutory authority to act quickly in the face of threats to food safety. Industry representatives also spoke out in opposition to the single-agency effort. John Cady, president and CEO of the National Food Processors Association, said that the current system can meet new challenges through stronger communication and coordination. "We are not convinced that a new layer of management, led by a single administrator, would achieve the goal of enhanced U.S. food safety," he said. Rather, improvements can be made through the creation of a unified food safety policy, drawing on the expertise of various existing agencies. 2. FDA Requiring Two-Week Turn Around Time for Responses to FCN Questions It has come to our attention that FDA is now requiring responses to questions on Food-Contact Notifications (FCNs) within ten business days; if the information is not received within that time frame, the Agency will "restart" the 120-day review period from the date of the submission of the additional information. We wanted to alert you to this fact, because it appears that the Agency is using this 10-day restriction to buy itself more time to review the FCN and, thus, it is important that notifiers respond to FDA requests within this time frame. Previously, FDA has been somewhat flexible in enforcing the 10-day requirement, agreeing not to restart the clock if information was provided within a reasonable time and the additional submission did not require a significant amount of review by FDA. Now, however, it appears that the Agency intends to be more rigid in its approach to the 10-day response period. Combined with this development, we also have been receiving some requests from FDA for additional information that seems unnecessary or insignificant. We will need to be vigilant to ensure that information requests and the 10-day response requirement are not used routinely to extend the 120-day review period, as occurred with respect to the 180-day review period for food additive petitions. Fortunately, we also have been told (and have experienced) that the Agency will now send requests for further information on FCNs to the notifier via facsimile or email, since they understand that, when these requests are sent via U.S. Postal Service, the requests can take as many as five working days to reach the notifier. 3. Consumer Groups Oppose Possible Nomination of Crawford as FDA Commissioner; Congressional Pressure Leads Astrue to Withdraw from Consideration Responding to rumors that a nomination for Dr. Lester Crawford as the next FDA Commissioner is imminent, a coalition of five consumer groups sent a letter to the White House stating their opposition to his possible nomination on the basis that he "simply is not qualified." The groups allege that Crawford has close ties with the food industry and that, during his tenure at FDA and the USDA, he routinely made decisions that jeopardized public health. You may recall from our previous letters that Crawford formerly was Administrator of the USDA's Food Safety and Inspection Service and Director of the Center for Veterinary Medicine at FDA. He currently is the head of The Center for Food and Nutrition Policy, which was most recently affiliated with Georgetown University and now is affiliated with Virginia Tech. The consumer groups alleged that Crawford's leadership at FDA and USDA "as documented in congressional hearings, was marked by poor decisions, dangerous policies, and mismanagement." The hearings the groups are referring to took place July 24-25, 1985, during which a House subcommittee reviewed the performance of FDA's Center for Veterinary Medicine. In a response letter, Dr. Crawford noted that his performance at FDA from 1978-80 and from 1982-85 was the subject of numerous awards and citations, including the Commissioner's Special Citation and the Award of Merit, FDA's highest award. The groups also stated that Crawford's Center for Food and Nutrition Policy receives substantial funding from the food and drug industries. In response, Crawford noted that "[v]irtually all universities receive industry and foundation funding along with federal and state monies. These monies . . . go into the general fund - not directly to centers and departments. The key point is that there cannot be strings attached to research outcomes nor can the universities endorse commercial products." Meanwhile, congressional opposition to any potential candidate from the food or drug industry has led the other candidate widely publicized as President Bush's favorite, Michael Astrue, to withdraw from consideration. In a letter to the White House, Astrue stated that "advancing further would be futile because of opposition in the Senate to a candidate with experience in the biotechnology industry." Astrue is an attorney who serves as senior vice president and general counsel of Transkaryotic Therapies Inc., a biopharmaceutical company based in Cambridge, Massachusetts. In the midst of the controversy, another name is being recirculated as a possible candidate: Peter Barton Hutt. Hutt is a former FDA Chief Counsel who currently is a partner with the Washington, D.C. law firm Covington and Burling. Hutt received his B.A. from Yale University, his LL.B. from Harvard University and his LL.M. from New York University. He is a member of the National Academies' Institute of Medicine, serves on many academic and scientific advisory boards and lectures at Harvard Law School. It is being rumored that his credentials may appeal to Sen. Edward Kennedy (D-Mass.), who chairs the Congressional subcommittee that will oversee the nomination of the next FDA Commissioner. 4. FDA's Washington, D.C. Area Mailrooms Reopen after Anthrax Scare "Presumptive findings" of anthrax on October 30th closed FDA's Washington, D.C. area mailrooms for nearly a week, leaving industry scrambling to find alternate ways to communicate with the Agency. On November 2nd, FDA issued a statement encouraging the use of electronic mail and fax as a means of communication, but provided no guidance as to how it would handle the submission of lengthy, time-sensitive FCNs. Fortunately, follow-up testing for anthrax at the FDA buildings revealed that the anthrax bacterium was not present after all, but fallout from the scare made it clear that the Office of Food Additive Safety (OFAS) is not ready to accept electronic FCN submissions despite the Agency's recent push for electronic submissions. One sticking point that remains with regard to electronic submissions is FDA's instruction that submissions must be delivered via CD- ROM, diskettes, Zip disks, or electronic tape. In other words, the Agency is not accepting a purely electronic, online delivery, but still requires physical delivery of the "electronic" submission. An email address designed to accept submissions would need to be secure, and FDA does not have a secure email address established at OFAS' current Washington, D.C. location. A secure email address will not be established until OFAS moves to its permanent location in College Park, Maryland. 5. FCN for Use of EVOH to Hold Food During Irradiation Stalled at FDA As we have been reporting to you, the National Center for Food Safety and Technology (NCFST) submitted to FDA an FCN for the use of ethylene/vinyl acetate/vinyl alcohol (EVOH) to hold food during irradiation. The FCN was submitted in late July and, therefore, was scheduled to become effective sometime in late November. However, NCFST's George Sadler informed participants at the 10th Annual Council on Ionizing Radiation Measurements and Standards in Gaithersburg, MD, that FDA is expected to reject the FCN. It is unclear to us what the holdup with the FCN is, but apparently it has come as somewhat of a surprise to NCFST, since NCFST felt that the crucial issues with the FCN were discussed and agreed upon with FDA during the course of presubmission meetings. FDA's position on the EVOH FCN is a setback to Sadler because it was to be the first in a series of FCNs for other polymers to be used during irradiation. 6. Consumer Groups, Industry React to FDA Safety Assessment on DEHP in PVC In the wake of FDA's safety assessment on di-(2-ethylhexyl)phthalate (DEHP) in polyvinyl chloride (PVC) medical devices, the consumer group Health Care Without Harm (HCWH) is asking FDA to reconsider its June 1999 citizen petition asking for a regulation or guideline to label PVC medical devices that leach DEHP. The June 1999 petition was denied by FDA on September 5, 2001, the same day the Agency released its DEHP safety assessment. HCWH's October 4, 2001 petition for reconsideration is slightly different from the original petition; reportedly, the new petition was altered to reflect FDA's findings in the safety assessment. You may recall from our previous reports that FDA's assessment involved the comparison of the doses of DEHP received by patients undergoing various procedures to "Tolerable Intake" (TI) values for DEHP to develop a general index of safety or risk with regard to patient exposure to DEHP. FDA noted that the TI/dose comparisons derived for many clinical scenarios were likely to overestimate the risk to the majority of the exposed patient population, since worst-case estimates of dose typically are compared to TI values intended to be protective for even sensitive individuals in the population. In estimating the dose of DEHP received by patients undergoing various procedures, and to identify the critical effects of DEHP in exposed experimental animals, FDA conducted a comprehensive review of the literature on point. In comparing the dose of DEHP received by patients undergoing various medical procedures to the TI value for oral or parenteral exposure, CDRH concluded that there is little or no risk to adults exposed to DEHP released from PVC medical devices in most applications. However, small segments of the population, such as premature babies undergoing multiple procedures during their stay in the neonatal intensive care unit, may be at heightened risk for the adverse effects of DEHP, compared to average adults, due to their increased exposure to the chemical and/or their increased sensitivity to the effects of the chemical. While the neonate may be more vulnerable to chemical insults than the adult, FDA appropriately stresses in the DEHP risk assessment that "[o]ther factors, such as the availability and safety of alternatives to DEHP and PVC, must also be considered in developing a risk management strategy" to address the issue of the safety of DEHP. Indeed, technically feasible alternatives to DEHP-plasticized vinyl medical products often do not exist. Nonetheless, HCWH's October 2001 petition asks FDA to require labeling of all PVC medical devices that may, under some circumstances, leach DEHP at or above TI values, specifically targeting labeling for applications with the most risk. According to HCWH, the Agency's September response to HCWH's original petition indicated that it is "exploring options to reduce exposure of some patient populations to DEHP. These options . . . may include new labeling for selected devices." HCWH also is recommending that FDA require labeling of all PVC medical devices that result in prenatal exposures to DEHP at any level; all PVC medical devices that may leach DEHP when used intentionally or inadvertently with lipid-containing nutrition or lipophilic drugs; and all medical devices that may cause nonsystemic effects as mentioned in Annex D of the FDA safety assessment. Generally, industry response to the safety assessment was positive. Most industry groups applauded FDA for acknowledging that there is minimal concern about the risk of adult exposure to low doses of these chemicals and that there often are no alternatives to the use of PVC medical devices containing DEHP. At least one industry group, however, criticized FDA for not incorporating all available data on DEHP. According to AdvaMed, the Agency did not include results from an important study that examined reproductive and developmental effects on neonatal rodents exposed to high dosages of DEHP and found complete or nearly complete recovery for rodents at sexual maturity after oral and intravenous exposure to DEHP. 7. Final Rule Prohibiting Use of Certain Biocides in Organic Food Is Ambiguous with Respect to Packaging Materials A final rule prohibiting the use of certain synthetic fungicides, preservatives, or fumigants in organic food handling contains ambiguous language that could be read to apply to components of packaging materials. On December 21, 2000, USDA's Agricultural Marketing Service issued the rule, pursuant to the Organic Foods Production Act of 1990 (OFPA), establishing the National Organic Program (NOP) (see 65 Fed. Reg. 80548). The NOP includes comprehensive standards relating to the production, handling, labeling, importation, and certification of organic products derived from agriculture and livestock. In addition, the NOP established a National List of Allowed and Prohibited Substances for use in organic production and handling operations (known as the "National List"), and a procedure by which individuals may petition for amendments to, or deletions from, the list. The rule became effective on April 21, 2001, and will be fully implemented on October 21, 2002. The NOP final rule imposes certain requirements for packaging materials used with organic food products. More specifically, 7 C.F.R. § 205.272 ("Commingling and contact with prohibited substance prevention practice standard") prohibits, in organic handling operations, the use of "packaging materials, and storage containers, or bins that contain a synthetic fungicide, preservative, or fumigant" (see 7 C.F.R. § 205.272(b)(1)). The OFPA and the final rule do not explain the meaning of "contain" used in this provision, and there is nothing in the legislative history or the preamble to the proposed rule to shed any light on the scope of this proscription. However, there is a strong argument that neither Congress nor USDA, which implements the NOP, intended to regulate organic food packaging materials that have no technical effect on the food (e.g., to ripen food, impart flavor, or protect the food against pests or spoilage). NOP personnel also have opined in verbal communications with Keller and Heckman that the final rule is not designed to reach food-packaging components that are not intended to affect the food product. There are several aspects of the final rule that imply USDA is not concerned with components of packaging that are not expected to migrate to, or commingle with, organic food. First, The National List (codified in 7 C.F.R. Sections 205.600 - 205.607) does not include typical food packaging components (e.g., monomers, or polymer additives) as either permitted or prohibited substances. The National List is simply silent on the use of packaging materials in contact with organic foods. Second, materials used to package food already are regulated under the Federal Food, Drug, and Cosmetic Act (FDCA) and FDA's food additive regulations. Although the NOP program is based on preferential standards (i.e., for determining the proper labeling of a food as "organic") and not food safety standards (which are FDA's responsibility), it is unlikely that USDA is interested in disallowing, through its use of "contain" in Section 205.272, the use of FDA-compliant food-contact materials. Lastly, other parts of Section 205.272 can be read to suggest that USDA is not concerned with the migration of de minimis levels of synthetic fungicides, preservatives, and fumigants used solely as packaging components, but rather is addressing in its final rule a more significant level of contact. For example, paragraph (b)(2) prohibits the "use or reuse of any bag or container that has been in contact with any substance in such a manner as to compromise the organic integrity of any organically produced product or ingredient placed in those containers, unless the reusable bag or container has been thoroughly cleaned and poses no risk of contact of the organically produced product or ingredient with the substance used." This provision clearly refers to synthetic fungicides, preservatives, and fumigants that are used with food packaging in a manner that allows them to be removed through conventional cleaning processes. These substances, to be sufficiently removed in compliance with this paragraph, would need to be incorporated superficially into the packaging material (e.g., in a surface treatment) and, thus, would be in a position in the material to contact and compromise the organic status of the food product. This organic standard, therefore, does not appear to contemplate those substances that are bound into the packaging material, and would only migrate to food at levels determined to be insignificant by FDA, if at all. In light of the foregoing, it is difficult to imagine that the NOP intends to prohibit the use of a component of food packaging that has FDA compliance for food-contact applications. What seems more plausible is that the NOP, in using the word "contain" in Section 205.272, intended only to reach those synthetic fungicides, preservatives or fumigants used to treat organically produced food, or its packaging, that could possibly compromise the organic integrity of the food. For example, a paperboard carton treated with a synthetic fumigant or a food preservative that is intended to act on the food itself would likely be considered under the NOP regulations to "contain" a prohibited substance if the components of the fumigant or preservative are not approved on the National List. However, the packaging materials themselves (in this example, the components of the paperboard) would not be considered prohibited unless they contain such high levels of a non-organic substance that it would migrate to the food in amounts sufficient to compromise the organic nature of the food. It is important, as the implementation date of the final rule nears, that USDA further clarify its policies relating to the operation of the NOP. Already, we have been surprised by comments made by USDA regarding the scrutiny that will be directed at processing aids used in organic production. Toward this end, companies may request that the NOP issue a formal policy statement on the packaging, or any other issue, through its website at: http://www.ams.usda.gov/nop/nop2000/nop2/contact_information.htm. In the meantime, the available evidence strongly suggests that packaging materials containing synthetic fungicides, preservatives, or fumigants with appropriate FDA food-contact status may be used with organic food under the NOP final rule. 8. The European Commission Is Calling for Comments by December 15, 2001 on a Proposed New Regulation for Polymeric Additives On October 25, 2001, the European Commission issued a draft "Discussion Note on Polymeric Substances Used as Additives in Plastic Articles" (EMB/755 Rev.1) to serve as the basis for developing a policy on the use of polymeric additives in the EU and calls for comments to be received no later than December 15, 2001. For a number of years, the European Commission and industry have debated the manner in which polymeric additives for food-contact plastics should be regulated. "Polymeric substances used as additives" (the new generic term used by the Commission) are those polymers that are added to another polymer to achieve a desired technical effect. Industry originally took the approach that these additives were cleared for use in contact with food in the EU, provided that the monomers used to form the material were listed on the "Monomers Directive" (90/128/EEC). The Scientific Committee on Food (SCF) and the Commission, however, held the view that these materials could not be considered to be encompassed within the clearances provided by virtue of the listings of their monomers on the Directive, because these materials generally have lower molecular weights and, thus, different toxicity than "high" polymers. The new policy proposed by the Commission would permit the use of polymeric additives in plastic articles covered by the Monomers Directive if the additive could itself be used as a finished plastic article (the so-called "basic polymers") and if it otherwise meets the requirements in place (i.e., it is formed from monomers and starting substances described in the Monomers Directive, meets the global migration limit, the overall migration limit, and the general safety standard of the Framework Directive 89/109/EEC). If these conditions are met, the polymeric substance can be used without further review. If these conditions are not met, then the substance is considered to be a "polymeric additive" and must be listed as an "additive" in Annex III of the Monomers Directive. For that purpose, a dossier must be presented for review by the Commission and the SCF with the relevant data on the polymeric additive as for any other additive, even if all of its starting substances already appear on the Directive. This will eventually lead to the establishment of a "positive list" of polymeric additives, the first draft of which is included as part of the Commission's Discussion Note. The Commission also proposes to establish a process by which interested parties can obtain an opinion from the authorities on whether a given substance is a "basic polymer" or a "polymeric additive." In these cases, a company can notify the Commission regarding the substance and request the opinion of the SCF. A model letter for requesting such an opinion is provided in the draft Discussion Note. As noted previously, the deadline for comments on the Commission's proposal is December 15, 2000. Comments should be transmitted by email to Luigi Rossi at luigi.rossi@cec.eu.int. At this time, the draft Discussion Note is not available online; please let us know if you would like a copy of the draft and we will have one forwarded to you. Also, please let us know if you believe that the Committee should file comments. 9. Canada's New Environmental Assessment Regulations Unlikely to Apply to Packaging Canada's new requirement, effective September 13, 2001, for environmental assessments of products regulated under its Food and Drugs Act is not likely to apply to most packaging materials. The New Substances Notification (NSN) program under the Canadian Environmental Protection Act now requires substances in products regulated under Canada's Food and Drugs Act (F&DA)-including pharmaceuticals, biologics, food additives, novel foods, personal care products, and cosmetics-to meet environmental assessment standards in addition to current requirements to comply with health and safety criteria. These products formerly were exempt from the need to be listed on the Domestic Substances List (DSL) through the filing of an NSN. The purpose of the new law is to ensure that these products undergo a thorough review for environmental impact, which previously has not been part of Health Canada reviews. The DSL is Canada's equivalent of the United States' Toxic Substances Control Act (TSCA) inventory. We do not expect this new requirement to affect packaging materials significantly for two reasons. First, packaging materials are explicitly excluded from the definition of "food additive" under the Canadian F&DA. Health Canada issues opinion letters confirming the safety of food packaging, but that is a voluntary process, not a legal requirement. In addition, most substances used in packaging also have other uses that would require their listing on the DSL. According to a September 4th Health Canada release, international monitoring has established that certain substances contained in products regulated under the F&DA are present at detectable levels in the environment. "While further research is required to understand their direct impact on ecosystems and indirect impact on human health, Health Canada recognizes the need to implement regulations to manage any risk these substances may pose," it said. To that end, Health Canada set out to develop, in consultation with Environment Canada, "effective and efficient regulatory requirements that would permit adequate and diligent environmental assessment of these products based on the most up to date scientific information." A panel of scientific experts from both the public and private sector will provide a technical foundation for the development of the regulatory framework and develop a research agenda designed to "allow for a better understanding of the potential effects of the release of pharmaceutical and personal care products into the environment and to look at appropriate disposal methods." When Health Canada issues regulations on environmental assessments of substances in products covered by the F&DA, we expect that the reviews will be undertaken by an Environmental Assessment Unit within Health Canada, in consultation with Environment Canada. In the meantime, companies seeking approval to import and manufacture products covered by the F&DA containing substances not on the DSL may be required to notify the Minister of the Environment under the NSN Regulations. Again, we expect most packaging materials already are on the DSL. Packaging material manufacturers should check with their suppliers or review Canada's DSL list to ensure that the components of the materials are already listed (this list is available on the internet at http://www.ec.gc.ca/cceb1/nsd/download/DSL.pdf). Substances not on the list, but which were on the market prior to December 1986 - along with other substances that have been sufficiently assessed for toxicity - will be nominated to the DSL by Health Canada. Substances listed on the Non-Domestic Substances List (NDSL) (available on the internet at http://www.ec.gc.ca/cceb1/nsd/download/NDSL.pdf) may be exempt from certain NSN Regulations if they are manufactured or imported in limited quantities. If the substance is, indeed, a new substance, and is not exempt under the NDSL, notification must be made to Environment Canada, providing all of the information required by the NSN Regulations; the forms are available on the Web at http://www2.ec.gc.ca/cceb1/nsd/eng/reporting_e.htm. More information on the NSN Regulations is available in the "Guidelines for the Notification and Testing of New Substances," which can be found on the Environment Canada web site at http://www2.ec.gc.ca/cceb1/nsd/eng/gui_e.htm. Health Canada has also established a web site with additional information on the program at http://www.hc-sc.gc.ca/ear-ree/index_e.html. 10. Australia and New Zealand Approve Irradiation of Herbs, Spices The health ministers of Australia and New Zealand have approved the use of irradiation with herbs, spices and herbal teas as an alternative to the use of ethylene oxide as a disinfectant. The food will have to bear a label stating that it has been irradiated. In approving the use of irradiation, the ministers stated that it has the same effect on food as ethylene oxide, but is safer. Studies on ethylene oxide have shown that the chemical is a potent genotoxic carcinogen. The ministers declined to approve the irradiation of nuts, concluding that nuts do not pose safety concerns. They noted that the World Health Organization conducted studies in 1994 and 1999 in which it concluded that irradiation of nuts is unnecessary. The ministers also announced that they soon will consider an application to irradiate tropical fruits. The Australian New Zealand Food Authority has asked for public comment on Sunbeam Australia's application requesting approval to treat tropical fruits with irradiation as an alternative to using chemicals such as dimethoate, fenthion and methyl bromide. * * * 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 Back to TopMore About SPI: Vision and Mission . Membership . Business Units . Regional Offices . News and Publications . Calendar of Events . Terms and Conditions of Use |
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 © Copyright 2005 The Society of the Plastics Industry.
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