D Environmental Protection Agency

Transcription

1 Are Treated Articles Headed for Reregulation under FIFRA? By David G. Sarvadi, Jennifer Bennet, Thomas C. Berger, and John B. Dubeck, Keller and Heckman, Washington, D.C. uring the past 18 months, the U.S. D Environmental Protection Agency (EPA) has caused a variety of consumer products including housewares, sponges, and toys to be pulled from nationwide shelves without notice. A new agency interpretation of an exemption applicable to antimicrobial treated articles was announced through a series of enforcement actions and has put manufacturers of pesticide treated articles and pesticides at risk of stop sale orders and civil penalties, despite the manufacturers efforts to obtain guidance from the agency and conform their behavior to the requirements of the exemption. The new interpretation has also created new registration and labeling hurdles for producers of antimicrobial finishes and preservatives for end uses. In response to recent agency action, nine companies that produce finished goods containing preservatives registered as pesticides, or the pesticides themselves, have joined in the formation of the Antimicrobial Treated Article Coalition (Coalition) and have sought a role in resolving the current uncertainty involving the regulatory status of treated articles. As technology has grown, the group of manufacturers, colorists, and chemists operating under the treated articles exemption has also grown to include those responsible for producing active wear, bedding, footwear, household linens, upholstery, wallcoverings, personal hygiene products, outerwear, medical drapery, and sports accessories with antimicrobial finishes. These producers are particularly concerned with developing safe, value-added products to meet the growing consumer demand for a fresher, more appealing environment. Background Historically, pesticides distributed or sold in the U.S. have been regulated primarily under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) which is administered by EPA. Central to FIFRA s statutory scheme is the concept of a pesticide registration (required under section 3 of FIFRA) which is essentially a license granted to a named registrant to sell or distribute a specific product for specified uses, Under section 25 of FIFRA, an exemption from all FIFRA requirements was created in 1975 for articles treated with or containing a pesticide so long as the pesticide used in the manufacture of the article is registered for that specific use and the pesticide is used solely to protect the article itself. This provision, which was amended in 1988, has long been known as the treated article exemption and currently reads as follows: The pesticides or classes of pesticides listed in this section have been determined to be of a character not requiring regulation under FIFRA, and are therefore exempt from all provisions of FIFRA when intended for use, and used, only in the manner specified. [a) Treated articles or substances. An article or substance treated with, or containing, a pesticide to protect the article or substance itself (for example, paint treated with a pesticide to protect the paint coating, or wood products treated to protect the wood against insect or fungus infestation), if the pesticide is registered for such usee1 Until recently, this exemption was a forgotten and noncontroversial provision. In the past few years, however, consumer concern regarding hygienic practices, microbial contamination, and safety has produced significant demand for products that contain antimicrobial protection. As a result, a large variety of antimicrobial-containing products have been developed and marketed in the U.S. According to EPA, products to which antimicrobials have been added during their manufacture include toothbrushes, juvenile toys and related items, kitchen accessories (eg., cutting boards), sponges, mops, shower curtains, cat litter, vacuum cleaner bags, pillows, mat- tresses, wrist bands, and tablecloths. Products with antimicrobial characteristics made from synthetic as well as natural fibers have appeared on the market. For the most part, these products were developed and marketed under the good faith belief that they were in compliance with FIFRA and the treated article exemption. Recent History In the early 199Os, EPA and the U.S. Food and Drug Administration (FDA) tested products being marketed as cold sterilants-products intended to sterilize medical devices in medical settings. A large percentage of the thenapproved formulations failed and EPA moved to remove the offending products from the market. The evidence caused the agencies to look at disinfectants as well and they determined that as many as half of the products then on the market did not work. This has caused EPA to be generally skeptical of antimicrobial claims. In the mid-lggos, EPA issued an enforcement order against Sears Roebuck for a mildew related claim on house paint that EPA claimed exceeded what was permissible under the treated article exemption. The link between articles and microorganisms as a matter of regulatory concern had been established. In early 1997, several aggressive advertising campaigns caught the attention of the Federal Trade Commission, EPA, and FDA. The products advertised included housewares and toys with antibacterial claims. EPA began to express concern over the claims being made for treated articles and announced in March 1997 that it intended to issue a Pesticide Registration (PR) Notice on the exemption to clarify its requirements. PR Notices are notices made available by EPA to pesticide manufacturers, formulators, producers, and registrants that are intended to clarify specific aspects of FIFRA and its regulations and to set forth agency policy. Other than a notice announcing their availability for pub- 14 Textile Chemist and Colorist Vol. 30, No. 9

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3 . lie comment, PR Notices are not published in the Federal Register or subject to formal rulemaking. EPA also released a draft-proposed revision to the treated article regulation. Then, without prior notice, the agency began to enforce the new (and still developing) policy: March Without publishing its promised classifications, EPA issues Stop Sale, Use, or Removal Orders (SSUR0)2 against several manufacturers and distributers of treated articles, including some who consulted with EPA s Office of Pesticide Program (OPP) staff prior to marketing their products. May EPA releases for comment a draft of a proposal to, inter alia, amend section (a). The draft would modify and expand the treated article exemption to address newly identified concerns and explicitly recognizes that modification of the published rule is needed. This draft is subsequently abandoned by EPA in favor of adopting a new interpretation of the existing rule. June-July EPA issues press releases announcing settlement in several enforcement cases and releases language negotiated in the consent orders for labels of affected products. In an April 22,1997, consent order, EPA and Hasbro agree to corrective advertisements in various print media and appropriate store and toy placarding. The corrective advertisements conspicuously state Microban Antibacterial Protection Built in to Protect the Toy! Inhibits the Growth of Bacteria! 3 September-October Additional settlements are reached, with different language accepted for the revised labels. In 3M, EPA agrees to the use of placards stating Inhibits Odor- Causing Germs in the Sponge and Does not disinfect or kill germs on surfaces. 4 November-December EPA inspectors visit at least one manufacturer, Lifetime Hoan Corp., to investigate a possible violation of FIFRA due to the sale of unregistered cutting boards with antimicrobial claims. No problems are noted. January 14, EPA issues SSUROs to seven companies, including Lifetime Hoan, that are participating in the International Housewares Show at Chicago s McCormick Place. The SSUROs allege that the companies are marketing unregistered pesticides. February-April Hasbro announces it will withdraw its products from the marketplace. Extended negotiations over label language by Lifetime result in yet different statements for new labels compared with that re- quired for relabeling existing stock and different from labels authorized by earlier settlements. Lifetime agrees to affix stickers to all allegedly violative products before resuming shipment. The stickers state that, Microban antibacterial protection is built in to inhibit the growth of bacteria that may affect the plastic in the product and does not protect users or others against food-borne bacteria. Always clean and wash the product thoroughly before each use. 5 Even with the stickers applied, EPA considers these articles to be illegal unregistered pesticides. As of this writing EPA continues settlement discussions with several of the other companies who received SSUROs in Chicago. Then, on April 17,1998, EPA published a Federal Register (FR) Notice finally announcing the availability, in draft, of the PR Notice which had been promised more than a year earlier. The FR Notice provided public notice of the agency s current enforcement policy with regard to treated articles and memorialized the new interpretation of the exemption that it had developed through enforcement actions during The notice reveals the full extent of the substantive modification of the treated article exemption that had occurred during 1997 and itself notes that the PR Notice contains new elements of the e~emption.~ Industry becomes even more confused. The draft PR Notice purports to clarify the types of claims permitted for pesticide products under exemption and to explain the requirement that the pesticides used to treat the article be registered for such use. EPA has been aware of the specific uses of these pesticides for a decade or more and on several occasions has specifically acknowledged the appropriateness of promotional statements regarding aesthetic benefits that can result, for example, when paints and shower curtains are treated to resist mildew and when cat litter is treated to resist odor. The New Policy Under the draft PR Notice, many types of products previously viewed as falling within the treated article exemption will require registration under FIFRA or will need to be relabeled andl or reformulated. The general policy that EPA has extracted from the settlements in enforcement proceedings indicates that unregistered products would be permitted only if (1) No implied or explicit public health claims of any kind are made; the words antibacterial, antimicrobial, or germicidal or related terms may not appear on the prod- uct label, collateral literature, or in advertising. Indeed, the only claim EPA proposes to allow is This product contains a preservative (fungicide, insecticide) built-in (or applied as a coating) only to protect the product. (2) The claims concerning the presence of a pesticide in the treated article are limited to protection of the treated article only. (3) When the permitted claim involves an antimicrobial ingredient (i.e,, for kitchen utensils, accessories, or other food contact items or for products involving human contact with bodily fluids such as bed pans, sheets, etc.), the permissible claim must be qualified by statements indicating that the presence of the antibacterial properties does not protect users and others against disease and that users should follow prudent hygienic measures; i.e., cleaning and washing the article. (4) The qualifying statement and preservative claim must appear in the same size, style, color, and prominence as other product characteristic claims. (5) The pesticide in a treated article is present only as a result of using a pesticide product that is registered under FIFRA and labeled for use in the treated article in question.6 EPA believes that claims that a pillow or mattress provide a healthier or safer environment, mitigate disease, or control the spread of allergens or insect vectors causing respiratory disorders are public health claims. In addition, EPA considers incorporation of an antimicrobial agent into an article of clothing (or any other article or substance) to provide a fresher, more esthetically pleasing surface by inhibiting the growth of odor causing bacteria, fungi, or mold and mildew imply benefits beyond mere protection of the treated article or substance. Both categories of claims would not be allowed under the new policy. Furthermore, the PR Notice indicates that, on a case by case basis, the agency will require that registrants list the specific articles that may be treated by the pesticide when registering and labeling the pesticide intended for incorporation into the treated article. Broad use patterns will not provide an adequate basis for use in unregistered treated articles. Until the PR Notice is issued in final form, articles containing label references to antimicrobial or antibacterial properties would be subject to enforcement action as illegal unregistered pesticides, unless the label also bears a specific statement that the treated article does not present any September 7998 Textile Chemist and Colorist 15

4 public health benefit and further that the label meets detailed requirements limiting the placement and prominence of the claim including color, contrast with other claims, type size, and location. It has been EPA s practice to bar immediately all shipments of products considered to be in violation by issuing manufacturers an SSURO and we expect this practice to continue. Effects of the New Policy Although EPA s FR and draft PR Notices are couched in terms of formalizing a long-standing and unchanging agency position, they represent a significant departure from earlier agency interpretation of the treated article exemption and will have a significant impact on the ability of numerous companies to market several types of treated mixtures and articles. The change in policy would prohibit claims, among others, for paint products that incorporate a fungicide in a coating to provide control of mildew-producing fungi in the dried paint film. Other examples of aesthetic benefits include incorporation of antimicrobial agents in pillows or mattresses to provide a cleaner environment or in articles of clothing to provide a fresher, more aesthetically pleasing surface by inhibiting growth of odor-causing bacteria. In fact, these kinds of claims were precisely the types intended to be allowed under the exemption. A discussion of the original exemption in 1975 as it relates to paints containing mildew control agents is illustrative. Under the draft PR Notice, EPA proposes to prohibit use of aesthetic claims on paints, coating, adhesives, and related products and to limit claims solely to in-can preservation. In the preamble to the original treated article exemption, EPA provided specific language that industry has used to describe mildew protection for paint surfaces. Among the 12 examples of permissible claims were included: Dry coating of this paint mildew resistant, Dried paint film resists mold fungus, Dry enamel coating resists discoloration from mildew, and Dried film resists stains from mold. g The proposed interpretation appears to prohibit these specific aesthetic benefit claims. EPA explicitly permitted, in its 1975 guidance, the use of the phrase mildew resistant in conjunction with other phrases limiting the claim to protection of the dried paint film; EPA s draft PR Notice uses mildew proof as an example of an impermissible phrase. The effective difference in the eyes of the consumer between these two phrases is not apparent nor is it clear that it is a distinction with a difference. Moreover, mildew resistance in certain kinds of house paint such as exterior coatings, coatings for bathrooms, and coatings for other damp locations clearly provide a consumer benefit that is an inherent characteristic of the dried film. Color and gloss are two other specific characteristics by which consumers distinguish both paint brands and paint products. Both color and gloss are adversely affected by mildew growth, and hence the mildewcide used to treat the product to prevent growth of mildew is, in fact, intended to protect the product (the dried film itself and salient characteristics important to consumers) and only incidentally provides mildew protection to the coated surface. Clearly, the exemption was intended to allow these products to be sold with these claims, which would not be permitted if the draft PR Notice goes into effect unchanged. By the terms of the preamble, the 12 permissible phrases are exemplary, and not exclusive, methods of describing the benefits of the pesticide used to treat a coating. Nor is it clear from the language of the exemption or the preamble that the exemption is limited to paints and treated wood. The plain language of the exemption allows any article treated with a registered pesticide to make claims for protection of the article itself. As long as the claims are properly limited and the claim is a fair and accurate representation of the relevant properties, it would appear that such claims are permissible under the exemption. lo Clearly, from the above discussion, the proposed PR Notice is a change from past practice. Moreover, if claims of aesthetic benefit are permissible because they contribute to the functionality of a coating product, the fact that an aesthetic benefit is claimed should have no bearing on whether the article should qualify for the exemption. EPA s proposed limitation to incan preservation is inconsistent with the 1975 rule and its preamble and the language of the exemption itse1f.l Because there has been no rulemaking to make a change in this aspect of the regulation since its adoption, under current case law, EPA is bound by the published 1975 preamble language.12 Moreover, it is also clear that the label statements used in the 1975 preamble were intended to be examples, both of the kinds of claims that could be made for paints and coatings (and other kinds of products such as caulking compounds, sealants, adhesive, and a myriad of other products in- tended for use in humid, outdoor, or moist environments) as well as the kinds of products that would be covered by the exemption. Clearly, it was anticipated that many other kinds of products would be developed as technology expanded (and greater use of water-based products was encouraged, in many cases by EPA s own rules) and that the list of products and claims were to be exemplary, not exclusive. To limit the kinds of products or claims that can be made, the regulation itself has to be changed. The development of the expanded registration requirements without appropriate opportunities for notice and comment rulemaking will undoubtedly have a significant impact on the manufacturers of treated articles, including those facilities that fabricate textiles that are then treated with antimicrobial finishes. Those manufacturers that provide finishes for end uses could be affected both by expanded registration requirements for the pesticides used in the finishes and the registration of the pesticide for the specific intended use, particularly in light of EPA s negative stance toward approving broad use patterns and by the loss of several kinds of product lines should the policy be adopted as proposed. The textile and finish industry will also feel the impact of the draft PR Notice on labeling requirements for end uses, which would restrict the content, placement, size, and color of claims identifying the antimicrobial finish. Industry s Response EPA s draft PR Notice represents a significant change in the agency s interpretation of the treated article exemption in that it proposes to prohibit claims for aesthetic benefits and nonspecific public health benefits for treated articles on the basis that such claims were never contemplated by the treated article exemption and are directed toward the user and not toward protection of the treated article itself. Furthermore, EPA s proposed interpretation, under which applicability of the exemption appears to depend on whether the user benefits from treatment of the article, goes beyond the plain language of the exemption. When the draft PR Notice and FR Notice were released to the public, a number of companies who make products all along the way from pesticides to finished consumer articles banded together to share information and to work with EPA to bring the regulatory scheme-now clearly outdated-into better synchronization with the demands of the marketplace. The group, + 16 Textile Chemist and Colorist 033 Vol. 30, No. 9

5 i I known as the Antimicrobial Treated Article Coalition, filed comments with EPA on the draft PR Notice on June 30, The Coalition, chaired by Jim Palmquist of 3M Co., includes Celanese Acetate, Kanebo Zeolite, and Thomson Research. The Coalition s Approach The Coalition believes that the treated article exemption was not intended to be interpreted as prohibiting truthful and non-misleading statements regarding the benefits of a pesticide in or on a treated article, as long as the terms of the exemption are met. Nor should it be. Further, the Coalition believes that EPA should provide a method to allow truthful claims regarding benefits that go beyond mere protection of the article itself. Consistent with Congress express intent in section 25 of FIFRA, EPA should exempt from the requirements of the statute those products that present little or no risk to human health or the environment, as those treated articles presently in commerce demonstrably are. A legally defensible and workable approach would be to continue to allow, under the present exemption, those claims, both express and implied, that are explicitly limited to the protection of the article itself and do not extend to other surfaces or objects, as long as other provisions of the exemption are met. Claims for the protection of other surfaces or objects, including some public health claims regarding food-borne pathogens, can and should be permitted through a system that is based on reviewing the prospective claims in the registration of the treating pesticide active ingredient. Full or reduced registration of the treated article should be required only for those articles that make specific claims for prevention of disease. The scope of EPA s regulation of other such products would require notice and comment rulemaking and should be developed in the course of discussions with all interested parties. Furthermore, the agency s approach should be based on a recognition that aesthetic, non-specific public health and other benefits provided by the antibacterial treatment of articles are important to society, consumers, and the economy and the ingredients used to produce these benefits are safe and effective when used according to the pesticide manufacturer s instructions. The agency s proposed actions would not simply require manufacturers or distributors of treated articles to make minor label changes. The proposed policy would result in the need for many products to be relabeled and/or registered under FIFRA, prohibit the sale and distribution of products that have been safely marketed for years, and could inevitably greatly slow, if not bring to a standstill, innovation in this area. Even under the most favorable circumstances, obtaining a pesticide registration requires several months; at worst, it may take several years. Therefore, the requirement to register these products and their component pesticides will result in a market disruption of 6-12 months to several years. In addition, because of the high cost of registration, it is likely that many of these products would no longer be available if registration were required. EPA cannot and should not determine unilaterally that it would prefer that such products not be sold and then effectively ban the products by calling the decision a policy. EPA should only be concerned with whether these products can be used safely and are effective. In other words, EPA should regulate them only to the minimal extent necessary. The Coalition is concerned that EPA has not fully considered the ramifications and paperwork burden of establishing a new class of pesticides subject to registration. If EPA s policies were to become effective as proposed, numerous pesticide registration applications for individual products (shower curtains, kitchen items, etc.) could overwhelm the agency s already strained review capacity. Also, before a registration can be prepared for review by EPA, the agency must develop and implement the policies, protocols, and procedures for review of such applications. In short, EPA is not prepared to register any of the articles that the PR Notice would render subject to regulation. In addition, EPA is not providing businesses with sufficient time to relabel products that could fall within EPA s new interpretation of the exemption with revised labeling. EPA originally proposed only a 30-day comment period on the draft PR Notice when its availability was announced in the Federal Register on April 17, The comment period was then officially extended to June 30, but because the proposal was not made in a formal rulemaking proceeding, comments were still being accepted into July. The final PR Notice will establish a date (now proposed as 60 days after publication) after which EPA expected full compliance with the notice. This deadline is proposed despite the fact that inventories for some of these products can last a year or more, and in spite of language in several settlement agreements that clearly recognized the longer lead time necessary to clear the distribution pipeline of old labels and old products. In the meantime, EPA expects manufacturers to immediately conform their labels to the specific details of the enforcement policy set forth in the FR Notice. However making changes in labeling and promotional material is a time consuming and expensive process that cannot reasonably begin until EPA s shifting position is finalized. The cost of the proposed change is significant. The Coalition expects that the annual impact of the proposed actions on the U.S. economy would be much greater than $100 million. This figure is based on an estimate of the activities necessary to follow EPA s new scheme, the number of products that would be affected, and the associated costs of the regulatory program finally adopted. The Coalition also believes that this estimate is conservative, Where Do We Go From Here? Perhaps most importantly, the Coalition is concerned that EPA s current FR/PR Notice approach for regulating treated articles is an attempt to use interpretive rulemaking power in a manner that offends established regulatory review procedures and any reasonable notion of due process. If EPA intends to substantively amend the treated article exemption, as the Coalition believes the current proposal does, it must do so by using the notice and comment rulemaking procedures required by the Administrative Procedures Act (APA). In addition, EPA s actions will have an immediate and significant adverse affect on many sections of the economy, including small businesses, without a concomitant public health benefit. These impacts must be critically reviewed by the Office of Management and Budget (OMB). The Coalition s goal is not to frustrate EPA s efforts to clarify or amend the treated article exemption, but rather to ensure that legitimate and necessary amendments to the exemption occur through the use of established procedures for substantively amending legislative rules. Where appropriate, certain pesticide treated articles may require registration, but the situations under which it is appropriate to impose the burden of registration under FIFRA should be developed and identified through rulemaking in an open and deliberative process. The Coalition is pleased that thus far EPA has expressed its willingness to work with industry and has solicited proposed alternatives to its current approach. Accordingly, the Coalition has recommended to EPA that it should: September 1998 Textile Chemist and Colorist 17

6 Open a formal rulemaking to address needed changes to the treated article exemption Maintain the status quo during the period while the changes and necessary supporting structure are developed Continue to enforce the exemption as written for cases of clear violations and where the agency has not given advice to companies contrary to the present position Regulate claims for treated articles by explicit registration of permitted article claims on the pesticides used to treat articles If registration is required for certain treated articles, provide test protocols and registration guidelines well in advance of changing its interpretation Determine compliance with any new labeling criteria which are properly established through proper notice and comment rulemaking at the time of manufacture of the article Adopt a time period to phase in whatever label and product changes are required by the new policy that is far longer than 60 days to accommodate current manufacturing and distribution practices Consumer articles treated with antimicrobial protection offer consumers a significant benefit with no compro- mise of safety. Clothing and other items made from treated fabrics fill a consumer need and contribute to a more hygienic, cleaner, and fresher environment. EPA should not stand in the way of innovation in these areas, but should work with the regulated community to assure the continued safety of these products. The Coalition is ready to assist. For more information about the Antimicrobial Treated Article Coalition (ATAC), please contact John Dubeck or David Sarvadi, c/o Keller andheckman, 1001 G St. N.W. Ste. 500 West, Washington, D.C ; telephone ; ATAC@ khlaw.com References C.F.R (a), FIFRA S 13[a), 7 U.S.C k[a), A SSURO has the immediate effect of impounding all products subject to the order, wherever located, and prohibits sale or distribution until the order is lifted. It is an enforcement tool that is coercive in extremis. 3. In re Hasbro Inc., No. FIFRA 97-H-06, Consent Agreement and Consent Order, EPA, April 22, In re Minnesota Mining and Manufacturing Co., No. 5-FIFRA , Consent Agreement and Consent Order, EPA, September 29, In re Lifetime Hoan Corp., No. FIFRA 98-H-04, Consent Agreement and Consent Order, EPA, February 13, Federal Register 19,256, April 17, Federal Register 19,257. Despite its assertion that the policy statement is a clarifica- tion of the existing rule, some of the elements include (1) terms such as antibacterial, an- timicrobial, germicidal, and germs are prohibited from appearing in the product name and on other labeling and advertising materials; (2) claims, formerly permitted, that the protection of the article by the applied pesticide treatment has an aesthetic benefit are prohibited; (3) and a proposal to prohibit the use of the phrase mildew proof on paint and a limitation of claims solely to in-can preservation Federal Register 19, Federal Register 28,246, July 3, It should be noted that the 1975 rule determined that such products are not pesticides, while the 1988 revision, without notice or explanation, changed the interpretation to the effect that treated articles were pesticides not requiring registration. The difference is material. In addition, section 25[b) requires exemptions to be developed by rulemaking; it follows that changes to such rules can only he adopted through a similar rulemaking. 11. The preamble to the 1975 rule provides the following example of acceptable label language, Dry coating of this paint mildew resistant. 40 Federal Register 28,246. The current exemption provides as a permissible example of the treated article exemption paint treated with a pesticide to protect the paint coating. 40 C.F.R (a), emphasis added. 12. Contemporaneous expression of agency intent published with a formally adopted rule are controlling on the agency as well as on the regulated community. Circumstances may change and suggest a need for a new approach, but the only way to make that change is through notice and comment rulemaking. Martin v. Occupational Safety and Health Review Common, 499 US. 144, 1991; Motor Vehicle Manufacturers Association v, State Farm, 463 U.S. 29,42,1983. I 6 Smoothness Appearance Replicas These replicas are used to visually evaluate the smoothness appearance of fabrics after repeated home laundering. The replicas represent grades of 1, 2, 3,3.5, 4, and 5. A grade of 5 would represent the smoothest appearance and a grade of 1 would represent the most wrinkled appearance. The replicas are designed for use with AATCC Test Methods 124 and 143. Order No ~ US. orders include shipping and handling. Orders outside U.S. must request a proforma invoice. AATCC P.O. Box 12215, Research Triangle Park, NC Tel: Fax: ordersdaatcc.org Visa, Mastercard or American Express Accepted I - I - 18 Textile Chemist and Colorist Vol. 30, No. 9