EPA's compliance advisory outlines the key requirements applicable to pesticide devices, including:
- Devices must be produced in an EPA-registered establishment and bear an EPA establishment number.
- Devices may not make claims that are false or misleading, including several categories of claims EPA has determined via notice and comment rulemaking are false or misleading.
- Entities importing devices must ensure that appropriate Notices of Arrival are submitted to Customs in connection with each import.
- States may impose their own requirements, and a number of states require pre-market registration of devices.
However, the compliance advisory does not break new ground, and leaves open a number of significant questions, including:
- The precise demarcation between devices and pesticides, including how novel technologies are classified!万博体育app手机登录咨询不讨论先例或提供附加指导,设备制造商在评价产品是否适当归为设备时应该知道这一点。
- Notably, as part of the 2023 Consolidated Appropriations Act, Congress enacted the fifth iteration of the Pesticide Registration Improvement Act, which contains a provision requiring EPA "to develop efficacy test methods for antimicrobial pesticide devices making public health claims." To date, EPA has not publicly released such test methods.
- What testing or other steps device manufacturers should take to ensure that their devices are safe.
Given EPA's continued focus on this area, as well as the lack of guidance on several key issues, companies should carefully monitor EPA developments and take affirmative steps to minimize the risk of a potential enforcement action.
Last week the European Commission published its long-awaited proposal for a Packaging and Packaging Waste Regulation ("Proposed Packaging Regulation" or "proposed Regulation"), and a Plastics Communication on an "EU Policy Framework on Biobased, Biodegradable and Compostable Plastics" ("Plastics Communication"). The Proposed Packaging Regulation is intended to replace the Packaging and Packaging Waste Directive 94/62 ("Packaging Directive") and to ensure that all packaging marketed in the EU/EEA is fully recyclable or reusable by 2030.拟议的打包规则如获通过,新要求和限制将对行业、经销商和消费者产生重大影响。欧洲议会和理事会现在必须通过所谓的“正常立法程序”审议拟议条例供通过,该程序允许提出修正并可能至少需要18个月
博客文章突出拟议打包规范将介绍的主要修改和新要求并概述委员会塑料通信的主要建议。
spanid="More8321+++/span优先重要修改是欧盟包装和包装废物法将采取规范形式而非指令形式。这与拟议条例第4条协调条款和将某些包装项目列入第3条定义一起,意在限制成员国对包装附加要求的尝试。禁止某些打包格式. 拟议条例还提议禁止单用打包格式,包括单用复合打包菜菜单用打包单用塑料分组打包单用宾馆微型打包单用塑料和复合盘盒和盒装HORECA区食品和饮料Compostability Requirements. The proposed Regulation would also require that particular categories of packaging (e.g., sticky labels attached to fruits and vegetables, very lightweight plastic carrier bags, and tea and coffee bags and single-serve units intended to be used and disposed of with the product) be "compostable in industrially controlled conditions in bio-waste treatment facilities." The proposed Regulation does not itself define the criteria that these types of packaging must meet to be compostable. However, its Impact Assessment states that companies may demonstrate the compostability of their packaging on the basis of existing EU harmonized standards, such as, e.g., Standard EN 13432:2000.European authorities are also likely to take into account the compostability criteria for plastics of the Plastics Communication (see below).The Proposed Packaging Regulation would also empower the Commission to subject other packaging items to the obligation to be compostable through delegated acts if justified and appropriate due to technological and regulatory developments impacting the disposal of compostable packaging and if the packaging meets the criteria of Annex III.
Other types of packaging that are not subject to the compostability obligation mentioned above would have to be designed in a way that they can be recycled without affecting other waste streams (such as the bio-waste waste streams).与原版建议相反,拟议打包规范似乎没有全面禁止可编译塑料聚合物。
Furthermore, all reusable packaging would be required to display a label on the reusability of the packaging and a QR code or another digital data carrier with additional reusability information.
Communication on a "EU Policy Framework on Biobased, Biodegradable and Compostable Plastics"
The Plastics Communication seeks to bring clarity on the different concepts of bio-based, biodegradable and compostable plastics, and complements the provisions of the Proposed Packaging Regulation, especially on compostability.EU Member State authorities and courts are likely to use the Plastics Communication's criteria to assess a company's claims on biobased, biodegradable and compostable plastics.
- The Plastics Communication defines biobased plastics as those made from biomass, instead of fossil resources. The claim "biobased" should only be used where the exact and measurable share of biobased plastic content in the product is specified, in order for consumers to know how much biomass has actually been used in the product. The Plastics Communication adds that the biomass used must be sustainably sourced, with no harm to the environment.
- Biodegradable plastics are defined as plastics that are "designed to decompose at the end of their life by the conversion of all their organic constituents (polymers and organic additives) mainly into carbon dioxide and water, new microbial biomass, mineral salts and, in the absence of oxygen, methane." The Plastics Communication clarifies that to biodegrade, plastics need a suitable environment and specific time. The Plastics Communication states that, when using such products, it should be made clear that they should not be littered, they should mention how long the product needs to fully biodegrade, and under which circumstances and environment (e.g., soil, water).
- The Plastics Communication defines compostable plastics as "a subset of biodegradable plastics designed to biodegrade under controlled conditions, typically through industrial composting in special facilities for composting or anaerobic digestion." For this type of plastic, the Plastics Communication states that only industrially compostable plastics, which comply with relevant standards, should be labelled as "compostable." Moreover, industrially compostable packaging should display how the waste item should be disposed of through the use of a pictogram.塑料通信还解释称,家用塑料堆肥应在当局监督下根据特定本地条件加以考虑,条件是使用这些塑料有明显的附加值。
Ass
Taken together, EPA's recent actions are significant and provide opportunities for companies to develop novel products that could have significant public health benefits. But they also highlight that significant uncertainty remains in this area, which presents risks that companies must carefully navigate to ensure regulatory compliance.
- Residual Antimicrobial Products
EPA's guidance regarding residual antimicrobial products sets out a new framework governing products that seek to make claims of residual efficacy against viruses or bacteria. This is significant: in the wake of the COVID-19 pandemic, the ability to use a product to kill viruses and bacteria on a surface not only at the time of application, but for weeks, months, or even years thereafter, has the potential for significant public health benefits. EPA had provided interim guidance in October 2020, but is now providing more detailed guidance and a test method. EPA's new guidance distinguishes between three categories of residual products: (1) residual disinfectants, (2) antimicrobial surface coatings and films, and (3) fixed/solid surfaces, such as copper, or other impregnated materials.
Residual disinfectants are essentially standard disinfectants demonstrating residual efficacy, and may make claims that they "kill" microbes for up to 24 hours after application.Coatings and films cannot make "kill" claims, and instead must contain disclaimer language, including the statement that the product is not a disinfectant but "can provide some additional protection against microorganism(s)] for up to X days." Fixed/solid surfaces and impregnated materials—for example, a copper door knob—may make claims such as the following: "kills 99.9% of [insert microorganism/s] within 1-2 hours of exposure when used as part of a comprehensive infection control program/protocol."
For second and third categories of products (surface coatings and fixed surfaces), a "stewardship plan" must be included as a condition of registration. The stewardship plan must address "the proper sale (including advertising and promotional materials), distribution, and responsible use of the supplemental residual coatings and antimicrobial surface products." EPA suggests that plans could include elements such as outreach to infection-control specialists regarding product efficacy and appropriate use!万博体育app手机登录development of a website to convey accurate information about the product and to "correct any false or misleading third-party statements or publications," and participating in regular meetings with EPA and others to discuss the product.
In requiring a stewardship plan, EPA is signaling that it intends to closely monitor these products, likely in part out of concerns that end users may view these products as a substitute for standard disinfection and thus not take adequate precautions. By making the registrations conditional on implementation of a stewardship plan, EPA has the ability to cancel the registration in a more streamlined fashion as compared to an unconditional registration.
Accordingly, companies developing products for which a stewardship plan will be required will need to carefully develop and robustly implement their stewardship plan, to mitigate the risk of a potentially abrupt registration cancellation.
Companies interested in developing these types of products, or adding claims to existing products, will need to generate appropriate data and secure registration with EPA (and the states) before making these claims. Applicants may also need to develop and secure EPA approval of test methods if they wish to make differing claims or seek to use products on use-sites not within the scope of EPA's guidance (for example, EPA's guidance for surface coatings and fixed surfaces does not cover porous surfaces). Ultimately, while this guidance provides a significant amount of information regarding these product categories, numerous questions remain about how EPA will implement it.
- Air Sanitization & Indoor Air Quality
The registration of the first product approved to kill both viruses and bacteria in the air (rather than just bacteria) is also significant: EPA has now approved a product that can kill 99.9% of viruses in the air if used as directed, and so there is now an opportunity for pesticides to be developed to directly combat the spread of viruses in the air. That said, significant challenges likely remain in developing products that are both effective and easy to use to treat the air. That is demonstrated by the instructions for the approved product, which may pose some practical issues—they call for closing or covering "all doors, windows, air vents and returns" in the room, spraying for 30 seconds, and then leaving the room for 12 minutes. The instructions also note that there is "no residual effect after room is reopened." Still, this product provides a novel use, and may pave the way for other types of registered pesticides that kill airborne viruses and bacteria.
As to the other category of EPA-regulated products that are intended to kill viruses or bacteria in the air—pesticide devices—EPA has not provided additional guidance. However, on October 5, 2022, EPA's Office of Radiation and Indoor Air requested comment regarding indoor air quality matters, and announced its intent to "promote and advance the widespread adoption of actions that lead to improvements in indoor air quality .... to help mitigate disease transmission (e.g., COVID-19)." Among other issues on which EPA seeks comment are (1) what the federal government can do to help improve "ventilation, filtration, and air cleaning practices to reduce the risk of disease transmission," (2) whether and how to develop a building recognition program relating to "ventilation, filtration, and air cleaning," and (3) "qualitative or quantitative features could be helpful in assessing or describing ventilation, filtration, and air cleaning parameters in a building." Because many of these cleaning and filtering technologies are pesticide devices, stakeholders may want to submit comments to EPA, which are due by December 5, 2022.
As we have written about previously, increasing the domestic supply of EVs and semiconductors, and expanding the country's clean energy capacity are among the core policy objectives of the Biden Administration.
Each of these supply chains could utilize these new MMOs, which are not currently listed on the Toxic Substances Control Act ("TSCA") Inventory. Because they are not listed, MMOs are subject to Section 5 of TSCA — a point that EPA confirmed in a separate compliance advisory.
Given this backdrop, manufacturers and importers of new MMOs must submit a Premanufacture Notice ("PMN") to EPA before manufacturing or importing these substances. Upon receipt of a PMN, EPA considers the potential hazards and exposures associated with the substance, and determines whether steps must be taken to reduce the risk to human health or the environment before the substance can enter the U.S.市场 关键是制造商和进口商按要求提交通知,包括因为TSCA禁止为商业目的使用个人知道或理应知道不符合TSCA方面要求的任何化学品,包括提交PMN或有资格免上这一要求的要求§ 2614. Manufacturers and importers do not need to submit PMN for MMOs already on the inventory (or that become added to the inventory).
EPA's announced plan to streamline this review process is good news for the EV, clean energy, and semiconductor industries. Under recent similar streamlining initiatives for biofuels, EPA has been able to complete its review for nearly all of the dozens of PMNs it has received since January 2022. This streamlining appears to be, in part, a response to concerns that EPA has acknowledged with respect to the speed of its new chemical reviews.
More details are forthcoming, and the EPA has announced that it will provide outreach and training sessions for interested stakeholders to describe the new streamlined review process.
While the Italian Decree provides companies with additional flexibilities to market their SUPs in Italy, companies should carefully assess the risks that may arise if EU Courts finally hold that the Decree is not compatible with EU law.
The Definition of Plastic
Article 3(1)(a) of the Italian Decree follows the definition of "plastic" of the SUPD with one important difference: it explicitly excludes from the definition "materials such as paints, inks, adhesives, and plastic coatings, weighing less than 10% of the total weight of the product, which are not the main structural component of the finished products" (emphasis added).
The Italian definition also does not follow the interpretation of the SUPD's definition of plastic reflected in the European Commission's Interpretative Guidelines ("Commission Guidelines"). The Commission Guidelines confirm that Recital 11 of the SUPD excludes from the concept of "products made partly of plastic" those materials to which "paints, inks and adhesives" are applied. However, the Guidelines also make clear that materials (e.g., paper and cardboard) with plastic coatings and lining are plastic materials or materials partly made of plastic and are subject to the SUPD's requirements and restrictions. Neither the SUPD's definition of plastic nor the Commission's Guidelines provide any exemption on the basis of a weight threshold.
A Delayed Entry Into Force of the Ban on Prohibited Single-Use Plastic Products
The Italian Decree also provides for a delayed introduction of the ban on SUPs listed in Part B of the Annex to the SUPD (e.g., cotton buds, cutlery, plates, etc.).
Article 5(1) of the Italian Decree mirrors Article 5 of the SUPD and prohibits the placing on the market of the SUPs listed in Part B of the Annex to the SUPD. However, Article 5(2) of the Decree also provides that the SUPs listed in Part B of the Annex may still be made available on the Italian national market "until stocks are exhausted, provided that it can be demonstrated that they were placed on the market before the date of the entry into force of the obligation referred to in paragraph 1" (emphasis added).
Presumably, the concept of placing on the market of Article 5(2) refers to the Italian national market, and not to the EU market, in line with the SUPD. Nevertheless, Article 5(2) indicates that all SUPs listed under Part B of the Annex that were already on the Italian market by January 14, 2022, may continue to be sold through the supply chain in Italy even if the SUPD's ban applies since July 2021.
An Italian Exemption for Biodegradable and Compostable Single-Use Plastic Products
Contrary to the SUPD, Article 5(3) of the Italian Decree provides an exemption from the ban for single-use plastic products that are biodegradable or compostable and are listed in Part B of the Annex to the SUPD. In particular, it exempts from the prohibition of Article 5(1) biodegradable and compostable materials certified in accordance with technical standard UNI EN 13432 or UNI EN 14995, with a percentage of renewable raw material of at least 40% (60% from January 1, 2024), if any of the following alternative conditions are met:
- It is not possible to use reusable alternatives to SUP food contact products listed in Part B of the Annex;
- The use takes place in controlled environments, which ordinarily and constantly deliver waste to public collection services, e.g., canteens and health facilities;
- Alternatives do not provide adequate guarantee in terms of hygiene and safety due to the specific circumstances of time and place;
- If the SUP is used for particular types of food or drink;
- The particular circumstances involve a multitude of people!or
- The environmental impact of the single-use alternatives is worse than the impact of the bio-based and compostable material, based on a lifecycle analysis by the manufacturer.
Arguably, the Italian Government would be justifying the exemptions of Article 5(3) on the basis of Article 11 of the SUPD, which requires Member States to ensure that their implementation of the SUPD does not compromise food safety. However, it is questionable whether the European Commission will agree with such interpretation, in particular considering that the Commission has repeatedly said that the definition of plastic also covers "bio-based and biodegradable plastics regardless of whether they are derived from biomass or are intended to biodegrade over time."
Thus, there is a risk that the European Commission may start an infringement procedure against Italy or that the EU Courts may otherwise hold that the Italian Decree's definition of plastics and its flexible exemptions for specific SUPs are not compatible with EU law. In effect, this would also have significant commercial consequences for those companies that relied on the flexible approach of the Italian Decree.
The Return Systems for Single-Use Plastic Bottles
Finally, Article 6(5) of the Italian Decree also requires that producers and their extended producer responsibility systems ensure that the post-consumer material [waste] of beverage bottles (with a capacity of up to 3 liters, including their caps and lids) listed in Part F of the Annex to the SUPD be collected and retuned back to their original manufacturers.
The easing of the coronavirus pandemic in the United States, with 67.7% of adults having at least one vaccine shot, provides the Biden Administration's EPA with a unique opportunity to take stock of its pandemic response and consider any potential policy improvements that could be made. This post focuses on two particular issues: (1) EPA's regulation of pesticide devices, including in particular indoor air quality-related devices, and (2) treated articles.
Pesticide Devices
The Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA") regulates both pesticide devices and pesticides. Pesticide devices operate by physical or mechanical means, and EPA has concluded that ultraviolet ("UV") lights and various types of air cleaning machines are pesticide devices, if claims to kill microbes or other pests within FIFRA's jurisdiction are made. Under FIFRA, devices are subject to fewer requirements than pesticides—for example, unlike pesticides, devices are not subject to pre-sale review and approval by EPA. Instead, EPA's principal substantive regulation of devices is premised on its authority to take action regarding "misbranded" devices. 7 U.S.C.万博体育app手机登录§ 136j. EPA interprets the misbranding requirement as mandating that a device be safe and effective for its claimed use and that devices not bear any false or misleading labeling—including efficacy claims that are not adequately substantiated.
While EPA requires sellers of devices to not make false or misleading efficacy claims, EPA has provided little guidance to industry regarding what efficacy data or other substantiation is adequate to support such efficacy claims. Indeed, in an April 12, 2021 letter addressing UV lights, EPA declined to provide detail regarding the type of substantiation it believes is appropriate for UV lights, other than to note that "[i]f claims are made against specific pathogens, EPA maintains that testing of the device against those pathogens on the specific substrate (e.g., E.coli on cloth) is necessary to substantiate those claims." Likewise, EPA has cautioned consumers about devices claiming to be effective against SARS-CoV-2, but has not provided guidance on what efficacy substantiation is required for such products.
This lack of guidance is in tension with recommendations by public health authorities that such devices may be important tools to combat the pandemic. For example, the CDC has indicated that upper-room UV light systems "can be used to control SARS-CoV-2 as a useful ventilation tool to consider in reducing the spread of infectious pathogens." Yet an entity marketing such a system would have little guidance as to what type of efficacy data might satisfy EPA, or what data EPA considers necessary to substantiate any given claim.
With the easing of the pandemic, EPA now has an opportunity to consider, in a non-emergency context, whether and how it can provide guidance to both regulated parties and consumers regarding appropriate efficacy claims and substantiation. There may well be significant challenges associated with such guidance, given the different types of devices and the fact that their effectiveness could potentially change depending on the environment in which they are used. Nevertheless, EPA plainly could develop some guidance (e.g., safe harbor specifications, generalized guidance regarding certain efficacy claims and data requirements, efficacy claims it views as impermissible or data it views as unreliable), and nothing prohibits the Agency from doing so after soliciting input from stakeholders via a public notice and comment process.
Treated Articles
Treated articles are products that are treated with an EPA-approved antimicrobial pesticide to kill microbes (e.g., a shower curtain treated to resist mildew). Under longstanding EPA regulations and guidance, claims for such treated articles are limited to claims to protect the article itself. 40 C.F.R.万博体育app手机登录§ 152.25(a), PR Notice 2000-1. Thus, claims to kill disease-causing bacteria or viruses may not be made in connection with treated articles. Instead, to make such claims, an entity must "register the article as a pesticide product," which is a lengthy, complex, and costly process. PR Notice 2000-1. Unlike pesticide devices, this class of products is subject to full-blown regulation under FIFRA.
Based on publicly-available information, EPA has registered few, if any, articles with claims to kill disease-causing bacteria or viruses. One of the few examples emerged earlier this year, when EPA announced that certain copper alloys used in hard surfaces (e.g., a doorknob) was the first such product registered to make antiviral claims. EPA has also provided draft guidance for hard-surface antimicrobial coatings. But for many other types of products, EPA has not developed test protocols or other guidance indicating what sort of data (efficacy, safety etc.) would be adequate.
It is not difficult to imagine the potential utility of such products, both now and in any future pandemic—especially a pandemic where surface transmission is a significant disease vector.manbext网页版For example, treatment of high-contact surfaces (e.g., public transit seats, light switches) could potentially provide significant public-health benefits, assuming efficacy, safety, and durability can be ensured.
To be sure, there may be significant challenges and questions associated with developing such products. But that is all the more reason for EPA to implement a process to work through these issues sooner rather than later.
Conclusion
EPA has played a key role in regulating antimicrobial products throughout the SARS-CoV-2 pandemic, and in expediting a variety of approval processes to provide immediate assistance in combatting the pandemic. Now that the pandemic appears to have abated, EPA could consider giving thought to lessons learned from this pandemic, including how to provide a broader suite of antimicrobial tools to combat the next pandemic, while ensuring that those products are in fact safe and effective for use.
As of July 3, single-use plastic products marketed in the EU/EEA must comply with the requirements and restrictions of Directive 2019/904 on the Reduction of the Impact of Certain Plastic Products on the Environment ("Single-Use Plastic Directive" – "SUPD"). To help Member States implement the SUPD into their national laws and apply its requirements, on May 31, 2021, the European Commission published its long-awaited Guidelines on the Scope of the SUPD. The Guidelines take different and controversial approaches on the scope the SUPD and the nature of plastics and continue to leave important issues unanswered.
The Requirements of the SUPD
The Single-Use Plastic Directive imposes restrictions and requirements on: (i) single-use plastic products that fall within the scope of the specific categories listed in the different Parts of the Annex to the SUPD, and (ii) all products made of oxo-degradable plastic (i.e., made of "plastic materials that include additives which, through oxidation, lead to the fragmentation of the plastic material into micro-fragments or to chemical decomposition").
In particular, the SUPD imposes the following requirements and restrictions on oxo-degradable plastic products and single-use plastic products marketed in the EU/EEA:
- Prohibition on Placing on the Market: The SUPD prohibits the placing on the market of all products that contain oxo-degradable plastic, as well as single-use plastic products listed in Part B of the Annex to the SUPD. Part B includes plastic cutlery and plates, beverage stirrers, beverage containers made of expanded polystyrene, including their caps and lids.
- Consumption Reduction Obligations: The SUPD requires Member States to ensure a reduction of the consumption of single-use plastic products listed in Part A of the Annex to the Directive. Part A of the Annex lists cups for beverages (with their covers and lids) and specific food containers as single-use plastic products that are subject to this consumption reduction obligation. To achieve this objective, Member States may impose different measures, such as national consumption targets, bans on the offer of the products free of charge at the point of sale, obligations to replace the products with reusable alternatives, and even outright bans on the marketing of the products.
- Product and Design Requirements: The lids and caps of single-use plastic products listed in Part C of the Annex, e, plastic beverage containers of up to three liters, must be designed in such a way that they remain attached to the container during the product's intended use.
- Minimum Recycled Content: The single-use plastic products listed in Part F of the Annex to the SUPD, e., beverage containers of up to three liters that are produced from polyethylene terephthalate as their major component, must be made of at least 25% recycled plastic by 2025 and 30% by 2030.
- Marking and Labelling Requirements: Sanitary towels, tampons, tampon applicators, wet wipes, tobacco products (g., plastic filters) and cups for beverages, as listed in Part D of the Annex to the SUPD, must carry a mark/label in accordance with Commission Implementing Regulation 2020/2151 informing consumers of the presence of plastic in the product, the negative impact of littering, and the product's appropriate waste disposal options. Implementing Regulation 2020/2151 imposes specific requirements on the wording, design, size, color, and position of the marking. It also allows producers to comply with the requirements by means of a sticker if the single-use plastic products are marketed before July 4, 2022.
- Extended Producer Responsibility: Member States must impose extended producer responsibility schemes on producers of single-use plastic food containers, cups for beverages, wet wipes, tobacco products, and all other products listed in Part E of the Annex to the SUPD.生产这些产品者需要支付收集、运输和处理垃圾的费用,以及清理垃圾和组织公众认识运动的费用。their caps and lids), through the implementation of deposit-refund schemes or separate collection targets for producers. The target is set at 90% by 2029. In practice, this obligation means that producers will have to increase the collection of their waste single-use plastic bottles and/or increase their contributions to the waste take-back schemes of which they are members.
- Awareness Raising: Member States must also take measures to inform consumers of re-use systems and waste management options at their disposal, and the impact of littering and other inappropriate waste disposal for all single-use plastic products listed in the Annex to the SUPD and for fishing gears containing plastic.
The European Commission's Guidelines: What is a Single-Use Plastic Product?
As explained above, most of the requirements of the SUPD apply to single-use plastic products that fall within the categories of products listed in the different Parts of the Annex to the Directive. The SUPD defines a "single-use plastic product" as a "product that is made wholly or partly from plastic and that is not conceived, designed or placed on the market to accomplish, within its life span, multiple trips or rotations by being returned to a producer for refill or re-used for the same purpose for which it was conceived." It also defines "plastic" as a "material consisting of a polymer [as defined by the EU REACH Regulation 1907/2006 on Chemicals], to which additives or other substances may have been added, and which can function as a main structural component of final products, with the exception of natural polymers that have not been chemically modified" (Art.3(1)SUPD.
这些定义表示,如果满足下列条件,产品即为单用塑料产品:- A产品由“塑料化”。取决于制作产品所用材料:(一) 聚合物或聚合物混合体除自然聚合物外“非化学修改;”和(三)可起产品主结构组件作用and
- The plastic product is "single-use."
The European Commission's Guidelines on the Scope of the SUPD provide different controversial clarifications on the concept of a single-use plastic product.
Polymer
To be a plastic product, the product must be made of polymers or mixtures of polymers. The SUPD refers to the definition of polymer included in the REACH Regulation 1907/2006, which states that a polymer is substance that meets the following criteria: (i) over 50 percent of the weight for that substance consists of polymer molecules (i.e., of molecules that contain a sequence of at least 3 monomer units, which are covalently bound to at least one other monomer unit or other reactant)!万博体育app手机登录and (ii) the amount of polymer molecules presenting the same molecular weight must be less than 50 weight percent of the substance.
Polymers will be considered to be plastic materials unless they are "natural" and they "are not chemically modified" (and they function as a main structural component of the products).
"Natural" Polymer
The Commission's Guidelines take the view that a polymer will only be natural if its polymerization process actually takes place in nature (i.e., it may not be the result of an industrial process even if it involves living organisms). According to the Guidance, this means that cellulose and ligning extracted from wood are natural polymers, while polymers resulting from biosynthesis via artificial industrial fermentation are not.
Natural Polymer that Are "not Chemically Modified"
Even if the substances used in the products are natural polymers, they will be considered plastic if they are chemically modified (and the substances function as a main structural component of the products).
The European Commission's Guidelines take the view that whether or not a natural polymer is chemically modified during its production process depends on whether the chemical structure of the polymer resulting from the production process (i.e., outgoing polymer) is different from that of the ingoing polymer.
Following this reasoning, the Guidelines argue that regenerated cellulose, in the form of lyocell, viscose and cellulosic film, is not considered chemically modified because the outgoing polymer is not chemically modified in comparison to the ingoing polymer. By contrast, cellulose acetate is regarded as a chemically modified polymer because the chemical modifications of the polymer occurring during the production process remain present at the end of the process (i.e., the chemical structure of the outgoing polymer is different to that of the ingoing polymer).
The Guidelines also clarify that if the chemical modifications result from reactions that are only taken place during the extraction process of natural polymers, the polymers will not be considered chemically modified.万博体育app手机登录The Guidelines especially mention cellulose and ligning that are extracted from a wood pulping process as examples of such natural polymers.
The Polymer Functions as a Structural Component of the Product
The last condition to qualify as a plastic product is that the polymer (other than a natural polymer that is not chemically modified) must function as a structural component of the product. The Guidelines state that this condition is a generic concept and clarify that the definition of plastic of the SUPD does not restrict or specify the type of product or the amount of polymer required to qualify as a plastic. Thus, for example, cardboard coated with plastic and paper cups with a plastic lining are single-use plastic products. In contrast, the recitals of the SUPD and the Guidelines make clear that the use of plastic paints, inks and adhesives do not render a product a plastic product.
The Plastic Product Is "Single-Use"
To be a single-use plastic product subject to the SUPD, the product must also be "single-use."
The SUPD will only apply to plastic products that: (i) are designed to be disposed of after one use, or (ii) consumers usually throw away after one use, even if the products are not initially designed/conceived as such.
The Guidelines provide various criteria to assess whether a plastic product is single-use or multi-use, including the product's washability or the possibility to empty and refill a product without damaging it. For example, plastic cups that can be reused after being washed will not be considered single-use plastic products.
The Guidelines also add that meeting the criteria on reusable packaging outlined in Article 3(2) of Directive 94/62 on Packaging and Packaging Waste ("Packaging and Packaging Waste Directive" – "PPWD") will demonstrate that a plastic packaging or product is not single-use (unless consumers typically perceive or use it otherwise).
Application of the SUPD and National Implementation
The requirements of the SUPD apply to products made of oxo-degradable plastic materials and to single-use plastic products listed in the Annex to the Directive that are placed on the market as from July 3, 2021. In contrast to other EU product legislation, the SUPD defines the concept of placing on the market within the context of the particular Member State, and not the EU/EEA as a whole. According to the Directive, "placing on the market" is "the first making available of a product on the market of a Member State" (emphasis added). In general terms, this essentially means that single-use plastic products (listed in the Annex) that are marketed in a particular Member State as of July 3 will have to comply with the requirements of the Directive even if they were already marketed in another Member State (for example, imported into the EU via another Member State) before that date. The European Commission is expected to publish Guidance providing further clarification on the concept of placing on the market for purposes of the SUPD.
To date, several EU Member States have already at least transposed some of the requirements of the SUPD into their national law. This is the case of France, Germany and Portugal. Many other Member States, such as Belgium, Italy, Poland and Spain are currently in the process of finalizing and adopting their draft national implementing laws.
For the first time ever, EPA has approved a pesticide making residual antiviral claims under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The approval may be a significant boon in the fight against COVID-19, but it also raises several key questions about EPA's broader approach to combatting the novel coronavirus.
EPA's Historic Approach to Residual Antiviral Products
Products that are sold with antiviral claims must typically be registered as pesticides under Section 3 of FIFRA, which can take 18-24 months. EPA has historically declined to approve products making residual antiviral claims (i.e., claims that a product remains effective against viruses hours, days, or longer after its application), and during the current pandemic has informed applicants that they must develop their own testing protocol in support of such products. Development of such testing protocols can be a lengthy and expensive process, with EPA taking a year to review the protocols alone. Once such a protocol is approved, an applicant would then need to generate efficacy data and submit a registration application.While this process helps ensure that robust efficacy data underlies such registrations, it can also limit innovation and hinder EPA's ability to react rapidly to developments like the COVID-19 pandemic.
The Granted Exemptions & Their Significance
In a shift away from its historic approach, on August 24, EPA issued two public health emergency exemptions to the Texas Department of Agriculture. The exemptions allow Texas to permit an airline and a orthopedics clinic to use a new surface coating that inactivates coronaviruses like SARS-CoV-2 for up to seven days. The exemptions last one year. The exemptions were issued pursuant to Section 18 of FIFRA, which authorizes EPA to grant state and federal agencies emergency exemptions for unregistered uses of pesticides to address emergency conditions. Section 18 exemptions allow applicant agencies to oversee the limited use of an unregistered pesticide in defined geographic areas for a finite time. Only federal and state agencies can apply for Section 18 emergency exemptions.
Unanswered Questions
This unprecedented use of emergency exemptions creates more questions than answers about EPA's long-term strategy to combat COVID-19 and its plan for residual disinfectant products, including:
How will EPA evaluate data about a residual antiviral product's efficacy? Texas submitted data demonstrating the coating's success against an EPA approved surrogate coronavirus and bacteria. However, EPA has not released a summary of such data, a description of the protocol used to generate the data, or an explanation of the standard by which such data will be measured. Accordingly, what EPA will require for future applicants remains unclear.
How will this impact EPA's issuance of regular registrations for products making residual antiviral claims? EPA has also not explained how the efficacy data requirements it applied to this Section 18 emergency exemption differed from those applicable to standard Section 3 registrations, other than to explain that the submitted data for this product do not "qualify for registration under section 3." What additional research is necessary to qualify this surface coating (or similar products) for registration under Section 3 of FIFRA? Will registration occur on an accelerated timeline, or will EPA continue granting emergency exemptions until the standard registration process is completed? EPA has indicated that it will provide information on at least some of these issues "in the coming weeks."
What about treated articles? This emergency exemption addresses only a surface coating that is designed to be regularly re-applied. To date, EPA has not addressed what efficacy data might be required for articles treated with antiviral products that are designed to last for months or even years. Will EPA develop an approach for evaluating and registering such products? EPA's Science Advisory Board found in June that such products could "have high potential in reducing or eliminating exposure to SARS-CoV-2," and thus should be a "high priority area to investigate."
EPA recently released a compliance advisory addressing pesticidal products that make claims to mitigate the novel coronavirus. While the advisory largely reiterates past guidance relating to pesticides, EPA has increased its emphasis on pesticidal devices, such as UV lights and ozone generators, which are subject to their own distinct set of regulations.
Most notably, EPA has emphasized that device marketers must have adequate data to support any claims they make to kill or mitigate the coronavirus. EPA advises that "[m]aking false or misleading labeling claims about the safety or efficacy of a pesticidal device may result in penalties under FIFRA.万博体育app手机登录Please note that ozone generators, UV lights and other pesticide devices may not be able to make claims against coronavirus where devices have not been tested for efficacy or safety for use against the virus causing COVID-19 or harder-to-kill viruses." (emphasis in original). The guidance also reminds manufacturers that devices must be produced in an EPA-registered establishment. Other requirements not mentioned in EPA's guidance, such as the need to maintain proper records and comply with requirements to import devices, also apply to pesticidal devices.
EPA has in the past brought significant enforcement actions against device manufacturers. For example, in 2013, EPA obtained a $2.68 million penalty relating to the production and sale of pesticidal devices.
The ongoing pandemic raises the question whether EPA should consider developing additional guidance to device manufacturers—potentially in the form of "safe harbor" guidance—describing efficacy data that the agency would regard as presumptively sufficient. Notably, the recent EPA Science Advisory Board draft report on COVID-19 issues observed that "[t]here are ample studies showing that UV, ozone, and heat (steam) are effective for virus inactivation at well described doses (e.g., temperatures)...万博体育app手机登录. the SAB recommends that the EPA include[] this issue in[] a guidance document." The report also observed that UV disinfection within HVAC systems could be a potential method of mitigating coronavirus transmission indoors.
Another possibility would be for EPA to create a voluntary program that would allow device manufacturers to submit efficacy data to EPA, in exchange for being pre-approved to make anti-coronavirus claims. One potential model would be EPA's "Safer Choice" program, which is a voluntary initiative that allows pesticide registrants to submit safety and efficacy data for EPA to review, with qualifying products allowed to use the "Safer Choice" label.
Safe-harbor guidance or the creation of a voluntary program would arguably be consistent with Executive Order 13924, released last month, which directs agencies to "accelerate procedures" for regulated parties to obtain "pre-enforcement rulings" "with respect to whether proposed conduct in response to the COVID-19 outbreak … is consistent with statutes and regulations administered by the agency." Such guidance or program might allow for EPA to provide greater certainty to consumers and device manufacturers, while remaining within the scope of EPA's authority to regulate pesticidal devices, which is more limited than its authority to regulate pesticides. See 41 Fed.瑞格51 065万博体育app手机登录19, 1976) (noting differences between device and pesticide regulatory authority).
At the same time, such guidance could raise concerns. For example, if EPA were to effectively treat any such guidance as binding on device manufacturers, that could potentially run afoul of Executive Order 13892 (as well as the Administrative Procedure Act), which generally prohibits guidance documents from imposing "new standards of conduct" on regulated parties. Unduly prescriptive or narrow standards could also discourage innovation in the pesticidal device industry.
To date, EPA has not yet made clear whether it will provide additional guidance relating to pesticidal devices and COVID-19, and if so, what the nature and scope of such guidance might be. Interested parties should keep a close eye on further developments in this area.
EPA on April 14 expanded its formal relaxation of certain FIFRA requirements for pesticides listed on EPA's "List N" of products expected to be effective against the coronavirus. This expansion builds on EPA's March 30 iteration of this temporary policy, which this blog previously discussed.
Notably, EPA has found "good cause" to take these actions without notice and comment in light of the pandemic, an issue that was not discussed in its March 30 guidance. EPA also characterizes these revisions as procedural in nature, and so subject to an exception to notice-and-comment rulemaking under the APA—a rationale that would apply regardless of the pandemic. 5 U.S.C.§553(b)表示EPA首次引用此大流行期间的这些例外,并可能预示未来努力快速修改其规则,如果机构认为有必要的话。值得注意的是,EPA引用这些例外,尽管自己的规则需要通知和评论,不包含这些例外。§152.46.
P>EPA扩展该临时政策为ListN杀虫剂提供以下额外灵活性,包括获取成分和注册杀虫企业:- Active Ingredients With Different Purities May Be Substituted for Registered Sources of Active Ingredients By Notification. EPA will allow an active ingredient, including non-commodity active ingredients, to be substituted for a non-similar active ingredient (i.e., the same active ingredient with a different purity), so long as (1) the alternate source is registered, (2) the nominal concentration of the active ingredient does not change, and (3) the only change necessary to the inert ingredients is limited to water. Previously, such changes would require EPA approval of an amended pesticide registration.
- "Similar" Non-Commodity Active & Inert Ingredients May Be Used By Notification.非通货性活性成分 /simational可用通知替换并立即发布销售活性成分源注册后,已注册企业也可生产N列表农药,只要EPA得到通知,产品可在通知提交后立即发售此前,公司不得不等待EPA批准 。
EPA还暗示,必要时开放提供更多灵活性,指出必须确保“美国人继续获取有效经批准的消毒剂,帮助消除COVID-19扩散”。