Tools Request permission Export citation Add to favorites Track citation. Share Give access Share full text access. Share full text access. Please review our Terms and Conditions of Use and check box below to share full-text version of article. Abstract Background Eicosapentaenoic acid EPA containing nutritional supplement can reverse weight loss and increase lean body mass in a perioperative period of patients with head and neck cancer. Conclusions Body weight changes in malnourished patients with head and neck cancer following surgery were not influenced by EPA additives to perioperative nutritional supplements.
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Close Figure Viewer. Browse All Figures Return to Figure. The U. In particular, retailers must make hazardous waste determinations for a diverse and ever-changing lineup of products, and the "reverse distribution" process raises a number of compliance questions exclusive to the retail industry. Given the goal of reducing regulatory burdens, implementation of the Strategy is expected to continue with the incoming Trump Administration. Challenges in Addressing the Retail Sector RCRA and its implementing regulations were developed primarily with the industrial sector in mind.
Further, retail industry waste is generated at episodic and unpredictable rates, and the point at which products are disposed of and the best way to make a hazardous waste determination is often unclear. For example, in , Wal-Mart settled with EPA for allegedly failing to manage properly hazardous wastes at retail locations, including products that were damaged or returned. As part of its settlement, Whole Foods is engaging in a Supplemental Environmental Protect to educate smaller retailers about hazardous waste laws and the importance of maintaining compliance.
States have also brought enforcement actions against retailers under their own hazardous waste laws, collecting millions of dollars in penalties. After establishing these concerns and receiving a number of recommended paths for resolution, EPA has begun to change its policies and determine a path forward for appropriate RCRA regulation of the retail sector. Responses and Planned Regulatory Changes for the Retail Sector EPA has taken a number of actions to clarify waste handling issues for the retail sector.
These revisions have come in the form of rulemakings on general and specific subjects, guidance letters to regulated entities, and memoranda to EPA Regions.
The modifications, addressing particular issues, are outlined below. To qualify for this exclusion, wastes must 1 be generated by individuals on the premises or a temporary or permanent residence, and 2 be composed primarily of materials found in wastes generated by consumers in their homes.
These provisions include a series of new standards for healthcare facilities that manage non-creditable and potentially creditable HWPs and reverse distributors that manage potentially creditable and evaluated HWPs. Under the Final Rule, prescription pharmaceuticals are considered solid waste at the healthcare facility level if they are destined for reverse distribution. By moving the hazardous waste determination down to the healthcare facility level from the reverse distributor level, the EPA attains jurisdiction over those items that are considered solid waste at the healthcare facility.
The shift also encourages healthcare facilities to manage all of their waste pharmaceuticals as hazardous waste, so they do not have to make HWP determinations. Although HWPs are subject to complex handling requirements under the Final Rule, healthcare facilities will no longer have to concern themselves with determining their generator status under RCRA, which depends on their monthly generation of HWPs.
To accomplish this Service, we embed code that such third party social networks provide and that we do not control. OTC items, including unsold retail items, undergo a reverse logistics process once those products leave the healthcare facility and may potentially be subject to reuse on a secondary market. For 35 years, South Australia remained the only jurisdiction in Australia with a container deposit scheme CDS , until January , when the Northern Territory Government introduced its own scheme. In —19, the return rate for aluminium beverage containers in South Australia was Return rates are calculated based on industry data on the number of eligible beverage containers sold in South Australia, against the number of those containers returned for a refund. Authorized states that must pass new legislation to implement the standards must do so by July 1, , and the remaining authorized states, which use non-legislative rulemaking processes, have until July 1, Generally, the Final Rule does not change how OTC products are processed through the reverse logistics process but codifies existing practice and policy into regulation.
Beyond the standards applicable to healthcare facilities, there is another layer of regulatory standards for processing HWPs, which apply to the reverse distributors. Overall, EPA considers the sum of these various standards to be streamlined waste handling requirements compared to the pre-Final Rule regulatory waste handling requirements.
While the new regulations may relieve healthcare facilities of certain burdens, the EPA considers the new regulations under Subpart P to impose standards that are more stringent than those currently in application. Accordingly, for authorized jurisdictions, the Subpart P provisions will only become effective at the local level upon state adoption. For non-authorized jurisdictions, the rules become effective on August 21, Authorized states that must pass new legislation to implement the standards must do so by July 1, , and the remaining authorized states, which use non-legislative rulemaking processes, have until July 1, Even though HWPs are subject to Subpart P, OTC items that have a reasonable expectation of use or reuse are not considered solid waste at the healthcare facility and are not subject to Subpart P requirements.
OTC items, including unsold retail items, undergo a reverse logistics process once those products leave the healthcare facility and may potentially be subject to reuse on a secondary market.
That said, if an OTC product has no reasonable expectation of use or reuse, then that product is subject to Subpart P requirements as a non-creditable non-prescription hazardous waste pharmaceutical. The healthcare facility must make this determination. Generally, the Final Rule does not change how OTC products are processed through the reverse logistics process but codifies existing practice and policy into regulation. Ultimately, since many of these products are likely to be used or reused, many of them should not be considered waste at the healthcare facility, which would otherwise trigger application of Subpart P standards.
HWPs, on the other hand, go through a reverse distribution process. These solid waste pharmaceutical drugs go to reverse distributors, which receive them and then facilitate the process, on behalf of manufacturers, of crediting healthcare facilities for these drugs.
HWPs at the healthcare facility are either non-creditable or potentially creditable, and at the reverse distributor level, they are either potentially creditable or evaluated for credit. Given the wide-ranging effects of the new standards, and the possibility of significant variation at the state level, stakeholders should carefully monitor the state implementation process during the next three years.
This is especially significant for those stakeholders operating in several states and those engaging, or planning to engage, in the disposal or shipping of HWPs across state lines. Since the sewering ban applies across the country on August 21, , the focus on state action is limited to the nicotine provision and Subpart P. OTC NRT products will still be viewed as acutely hazardous waste in those states that fail to adopt the nicotine changes. States will therefore have to make a decision as to whether to maintain the status quo or deregulate per the Final Rule.
By contrast, the 48 authorized states must adopt the Subpart P provisions by either July 1, if implemented through regulation , or July 1, if implemented through legislation. In addition, the Final Rule merely establishes a regulatory floor, and states may adopt more restrictive measures for handling and processing HWPs. This means that unlike the nicotine provisions, there is the potential for significant variation in how states implement Subpart P. Variation could also arise with some states restricting commingling of hazardous and non-HWPs. Different states might have different waste container labeling requirements, container standards, or accumulation time limits.
There are also shipping standards that could vary from state to state. For healthcare facilities with facilities in multiple states, state variation would be problematic. For example, a chain pharmacy with pharmacies in all 48 states might have to comply with 48 variations of Subpart P standards. Difficulties could also arise for regulated entities that do not operate in multiple states. Oftentimes, an HWP will travel through multiple reverse distributors before it reaches the TSDF and could conceivably travel through four locations in four different states before it reaches the TSDF in a fifth state.
Because accumulation times are cumulative and consistent labeling is important throughout the reverse supply chain, even those healthcare facilities that operate in a single state could face significant challenges if substantial variations arise at the state level. Given the importance of achieving state-level consistency for the new regulations governing the handling of HWPs, healthcare facilities and reverse distributors will need to implement a coordinated advocacy campaign at the state level. Unless such efforts are made well in advance of the and deadlines, supply chain stakeholders could face substantial headaches in seeking to ensure compliance with Subpart P standards in each state across the country.
Pharmaceuticals legitimately used, reused, or reclaimed are not HWPs, nor are over-the-counter pharmaceuticals, dietary supplements, or homeopathic drugs if they have a reasonable expectation of being legitimately used, reused, or reclaimed. Reverse logistics centers manage nonprescription items that have become unsalable at a retail store and are not solid wastes because they have a reasonable expectation of being used, reused, or reclaimed.
Use our search tool to find a site ID number for a facility. Federal regulations require large and small quantity generators of hazardous waste to. A U.S. Environmental Protection Agency (EPA) identification number is a site-specific number issued to an owner/operator to track hazardous waste as it moves from its site of creation to its final disposal. States that use the EPA Standard Form ask for the EPA ID Number.
In authorized jurisdictions, the local or state government has primary enforcement authority; the EPA retains enforcement authority in these jurisdictions but cannot enforce requirements that are stricter than the federal standards. An example might be saleable returns or drugs destined for drug donation programs. JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
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