President Obama Signs Landmark TSCA Reform Legislation into Law, as US EPA Begins Implementation

On June 22, 2016 President Barack Obama signed into law the “Frank R. Lautenberg Chemical Safety for the 21st Century Act,” the landmark legislation modernizing the decades-old Toxic Substances Control Act (TSCA).   The Lautenberg Act is the first substantive update of TSCA since it was passed 40 years ago in 1976 and signed into law by President Gerald Ford.  The Lautenberg Act was approved by large majorities in both houses of Congress: a 403-12 margin in the US House on May 24, 2016, and by a unanimous voice vote in the US Senate on June 7, 2016.

The Lautenberg Act became effective immediately upon the President’s signature, and US EPA already is moving quickly to begin implementation of the Act’s provisions.

In materials posted to its website shortly after President Obama signed the legislation, EPA stated that it is “developing an Implementation Plan to guide the agency’s effort on successfully meeting the deadlines in the new law, including among others:

  • Identifying the initial ten Work Plan chemical risk assessment;
  • Establishing a process and criteria for identifying high priority chemicals for risk evaluation; and
  • Issuing a procedural rule that establishes EPA’s process for evaluating risks from high-priority chemicals.”

Significantly, EPA emphasized that the “most immediate effects” from the new law “will be on the new chemicals review process.” In contrast to the procedure under the old TSCA whereby EPA could simply let the 90-day review period for a PMN (or SNUN) expire without taking action, the Lautenberg Act requires EPA to make a formal affirmative determination regarding whether a new chemical (or a significant new use of an existing chemical) presents an “unreasonable risk of injury to health or the environment under the conditions of use” before the chemical can be manufactured, imported or processed in the US.

Because this new requirement is now in effect, EPA announced that the Lautenberg Act “effectively resets the 90-day review period” for companies that submitted PMNs (or SNUNs) prior to the President’s signature on the Act. In other words, for PMNs and SNUNs submitted before June 22, the 90-day clock was restarted on that day.  EPA also stated, however, that it “will make every effort to complete its review and make a determination within the remaining time under the original deadline.”

EPA also stated that over the next several weeks, it “plans to begin making information available on opportunities to learn more about the changes in the new law and how and when specific stakeholder engagement will begin to take place.”   EPA stated that, among other things, the “opportunities for input” may include briefings, webinars, public meetings, and comment periods.

In addition EPA announced that it plans to soon begin the process for consulting with stakeholders about developing the rule required under the Lautenberg Act to collect new fees to “help defray the costs of administering the provisions on collecting and managing information, implementing the new chemicals program, and evaluating and regulating existing chemicals.”

EPA’s actions to interpret and implement the numerous new provisions and requirements in the Lautenberg Act in the weeks and months ahead will be critically important and will set the tone for EPA’s long-term approach to the new law. EPA must soon begin work to develop and issue several significant rulemakings that must be completed within one year of the Law’s enactment (i.e, by June 22, 2017), as well a number of policies, procedures, and guidance documents that must be completed within two years of enactment (i.e. by June 22, 2018).  EPA also must begin its efforts to develop early lists of existing chemicals for prioritization and risk evaluation, collect data on chemicals and initiate risk evaluations on chemicals.  Squire Patton Boggs will monitor EPA’s actions closely.

Implications Of The Brexit Vote On UK Environmental Law And Policy

Following a referendum which has polarised the nation, the people of the UK have voted to leave the European Union. Stepping away from the political rhetoric and posturing, it is worth reflecting on some of the more practical issues which will arise from this decision, such as how it could affect our environmental law landscape.

From a historical perspective, the UK was once referred to as the ‘dirty man of Europe’, with relatively lax levels of environmental regulation and standards. Since joining the EU in the 1970s, however, environmental standards imposed, largely through EU legislation, saw a significant strengthening of the UK’s environmental protection regimes and of environmental standards.  Today, the majority of environmental legislation in the UK is derived from the EU, with national law only having to deal with enforcement and penalties.  So what does UK’s exit from the EU mean for environmental law from a practical and policy perspective?  Read more for insights on what to expect next.

 

When Allergens Go Wrong: UK Potential Penalties For Food Adulteration And Breach Of Food Information And Safety Laws

Penalties imposed by the courts in relation to the adulteration of food can be serious. The Guardian and other papers in the UK reported recently that an Indian restaurant owner has been imprisoned for manslaughter following the death of a customer who suffered an allergic reaction (a severe anaphylactic shock) in January 2014 after eating a takeaway which contained peanuts, despite the fact that he made his severe allergy known to staff. In the case, the court reportedly heard evidence that cheaper ingredients had been substituted for spices.

The case also highlights the even more serious consequences for customers if allergens are not properly controlled and/ or where the allergen information given to customers is not correct. Clearly, allergy sufferers can be unwittingly exposed to potentially fatal risks and as such they may pay the ultimate price. Any court is unlikely to look favorably on a business which puts profit before personal safety and knowingly substitutes ingredients for financial reasons.

Financial penalties for breach of food information and food safety laws for manufacturers, restaurateurs and supermarkets are also significant, and have recently increased. On 11 March 2015 the previous £20,000 fine limit for magistrates in England and Wales was removed (under the Legal Aid, Sentencing and Punishment of Offenders Act 2012). For a conviction under the Food Safety Act 1990 in the magistrates’ court, the level of fine is now an unlimited amount (which is also the case for trial in a higher court). Relevant offences include: selling food not complying with safety requirements; selling food not of the nature, substance or quality demanded; and falsely describing or presenting food, all of which could potentially be relevant where undeclared allergens have been used.

Following the removal of the fine limit, in February 2016, definitive guidelines published by the Sentencing Council in 2015, came into force. The guidelines included food safety and hygiene offences for the first time (earlier guidelines covered corporate manslaughter and health and safety offences resulting in death only, although fine levels for these offences have also been updated in the new guidelines).

All indications to date are that the application of these guidelines by the courts will almost certainly result in significantly higher penalties for organisations convicted of such offences. They apply to organisations in England and Wales which are sentenced on or after 1 February 2016 (regardless of the date of the offence) and to all individual offenders aged 18 and over. The guidelines include a number of tables setting out starting points and ranges for sentences for the various offences. For example, large organisations (those with a turnover of £50 million or more) could face fines of up to £3 million for food safety and hygiene offences. It will be at the court’s discretion to go above these figures if they consider a case to be exceptional.

The Sentencing Council has published a series of case studies to assist the courts in imposing sentences for the various offences. They consider the steps in the guidelines and the facts that should be taken into account at each of the key steps. They confirm which range and starting point is appropriate but do not actually recommend what fine should be imposed. For food safety and hygiene offences:

  • Culpability will be rated low to very high – with very high being “a deliberate breach of or flagrant disregard for the law” and low being “the offender did not fall far short of the appropriate standard”.
  • Consideration must then be made to whether there was a low or serious risk of an adverse effect on the individual. For example, a “category 1” harm may have serious adverse effect(s) on individual(s) and/or have a widespread impact.
  • The court is then required to focus on the organisation’s annual turnover or equivalent to reach a starting point for a fine. Offenders which are companies, partnerships or bodies delivering a public or charitable service are expected to provide comprehensive accounts for the last three years, to enable the court to make an accurate assessment of its financial status.

Given the increase in potential fines for commission of a food safety and hygiene (and/or health and safety offence) the overall approach to risk management by operators and senior management will in our view be increasingly important. Prevention, rather than reaction, will help to minimise the risks of potentially very large fines and improvement in compliance systems before an incident occurs will help to achieve this.

The extent of precautions a business puts in place to protect against food adulteration will be relevant when seeking to establish a defence to such offences. Companies and professionals in the food industry should take all reasonable precautions and exercise all due diligence to avoid committing offences under UK legislation. Whether the actions which have been taken meet the test of ‘all due diligence’ and ‘all reasonable precautions’’ will ultimately be decided by the courts on a case to case basis. There is no ‘magic formula’, nothing that all businesses can do that will mean they will automatically meet the threshold of the due diligence defence. It will depend on all of the circumstances in the particular case. However, suitable precautions might include:

  1. Horizon scanning exercises to assess the risks and weaknesses in global supply chains or in the information given to a business by its suppliers;
  2. Considering and implementing safeguards to protect against identified risks, for example supplier audits, or random sampling of goods, all of which should be adaptable when horizon scanning identifies increased risk;
  3. Ensuring transparency of supply chains and robust traceability systems;
  4. Following recognised industry or trade body guidance, such as standards developed by the Food and Drink Federation or the British Retail Consortium;
  5. Devising and testing crisis management plans for when a potential issue is identified;  and
  6. Documenting all systems and due diligence measures agreed and carrying out audits to check compliance with those systems across the business.

In addition to such practical precautions in relation to the products themselves, it may be sensible to consider your supply agreements and relationships. Supply chain partners can negotiate responsibility for recalls at the beginning of their relationship and may want to consider which party should manage the administration of any recalls and interaction with regulators. Unduly pressuring suppliers (for example, by failing to comply with basic payment terms) may inadvertently lead to them, in turn, cutting corners and increasing your exposure to unacceptable risks (for more insights on this, please visit our Global Supply Chain blog).

In terms of how allergen information is provided to customers, the FSA issues Guidance in relation to the provision of allergen information for loose foods (which would cover food supplied in restaurants). It states that where allergen information is not provided upfront in writing, signposting a customer to where they can get this information is required. This could be, for example, by way of a sign, notice or statement at the till point, on a menu board, or on the menu. For example, a sign might direct customers to ask staff for allergen information (although reliance only on verbal communication might make it difficult to demonstrate effective compliance). It also highlights that businesses should consider any risks of cross-contamination if they claim a food is free from a particular allergen.

Under the Food Information Regulations 2014, the primary enforcement mechanism in England for failure to comply with the EU Food Information for Consumers Regulation is Improvement Notices. However, failure to comply with allergen labelling/information requirements for both pre-packed and loose foods may still be dealt with from the outset as a criminal prosecution in the magistrates’ court. Clearly, as the recent manslaughter conviction shows, where the failure results in injury or even death, businesses can be prosecuted under other legislation (and civil claims may also follow).

US Congress Passes Landmark TSCA Reform Legislation

On June 7, 2016 the US Congress passed the “Frank R. Lautenberg Chemical Safety for the 21st Century Act,” the landmark bipartisan, compromise legislation to overhaul the Toxic Substances Control Act (TSCA).    The Lautenberg Act is expected to be signed into law by President Obama very soon.

As passed by Congress, the Lautenberg Act makes many significant changes to the current TSCA law, including:

  • Requiring US EPA to evaluate chemicals (both new and existing chemicals) to determine whether they present an “unreasonable risk of injury to health or the environment under the conditions of use”;
  • Prohibiting US EPA from considering costs or other non-risks factors in chemical evaluations and requiring the Agency to consider potentially exposed or susceptible subpopulations in the evaluations;
  • Allowing chemical manufacturers to ask US EPA to evaluate a chemical;
  • Giving US EPA authority to issue administrative orders to require testing of chemicals;
  • Requiring US EPA to reduce the use of vertebrate animals in testing;
  • Eliminating the “least burdensome” requirement for chemical regulations, making it easier for US EPA to restrict – or ban – chemicals;
  • Preempting state chemical regulations under certain conditions;
  • Putting limits on confidential business information (CBI) claims and allowing US EPA to share CBI with states; and,
  • Allowing US EPA to charge higher fees for chemical reviews.

Because the Lautenberg Act makes so many significant changes to the current TSCA statute, US EPA’s actions to interpret and implement the numerous new provisions and requirements in the Act will be critically important – especially during the next 1-2 years.  US EPA must develop and issue a number of policies, procedures, guidance documents and formal rulemakings during this time, as well as begin to develop early lists of existing chemicals for prioritization and risk evaluation, collect data on chemicals and initiate the risk evaluations.  Moreover, US EPA must begin to give greater scrutiny to Pre-Manufacture Notices (PMNs) for all new chemicals (and Significant New Use Notices (SNUNs) for new uses of existing chemicals) and evaluate them for safety under their conditions of use, require more testing of chemicals, and take stronger action on chemicals that US EPA determines present an unreasonable risk of injury to health or the environment.  The impacts of US EPA’s actions under the Lautenberg Act on the manufacture, import, processing, distribution and use of chemicals – and products containing chemicals – in the United States will be significant and far-reaching.  A comprehensive analysis of the Act is available here.

Taking The Field – Obligations On Employers Under The New UK Control Of Electromagnetic Fields At Work Regulations 2016

From next month, employers will be required to consider specifically the risks posed to their employees by electromagnetic fields (EMFs).

What are EMFs?

EMFs occur wherever a piece of electrical or electronic equipment is used, from an electric kettle or lap top computer through to an MRI scanner or satellite dish.  EMFs are likely, therefore, to be present in most modern workplaces.  Although there is no current scientific evidence that EMFs are responsible for long-term health consequences, it is well established that (depending on the frequency of the EMFs waves) they can cause short-term effects, such as nausea, vertigo, twitching and heating up of body tissue.

What changes are being made to the law?

Subject to Parliamentary approval, the Control of Electromagnetic Fields at Work Regulations 2016 (CEMFAW) will be introduced on 1 July 2016.  CEMFAW transposes into UK law the requirements under EU directive 2013/35/EU on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields) (20th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC).

Although employers are already required under the Management of Health and Safety at Work Regulations 1999  to assess the general risks posed to employees and others by risks posed by their undertaking, CEMFAW relates specifically to risks posed by EMFs.  For example, CEMFAW will require employers to:

  • ensure that exposure by employees to EMFs is below the relevant exposure limit values (ELVs) (regulation 4);
    assess the levels of EMFs to which their employees may be exposed (regulation 5);
  • where appropriate
    • devise and implement an action plan to comply with exposure limits (regulation 7);
    • assess the risk of an employee’s exposure to EMFs (regulation 8); and
    • eliminate or minimise the risks from EMFs (regulation 9);
  • provide information and training to employees on any particular risks posed by EMFs (regulation 10); and
  • provide health surveillance and medical examinations to employees who are exposed to EMFs in excess of the ELVs (regulation 11).

The obligations relating to ELVs do not apply to military installations or during military activities, to the use of MRI scanners in the health sector or where the HSE has granted a written exemption to employers.

How can employers assess the levels of EMFs to which their employees may be exposed?

The first step for all employers under CEMFAW will be to assess the levels of EMFs to which employees are exposed.  Fortunately, draft guidance published by the Health and Safety Executive (“HSE”) contains a table setting out a non-exhaustive list of low exposure electrical and electronic equipment (including many items used in offices, such as computers, IT equipment and photocopiers) and advises, that where a business uses only these items, no further action need be taken unless there are employees at particular risk (such as expectant mothers) or exposure could present a risk of indirect effects (for example, interference with passive implanted or body worn medical devices).  The HSE guidance also contains lists of those sources of EMFs and activities which may pose risks (for example, radio and TV broadcasting systems and devices, dielectric heating and welding, and industrial electrolysis).

Although ELVs set out the limits of exposure to EMFs, they can be difficult and expensive to measure directly.  Therefore, CEMFAW also contains a separate set of values, Action Levels (“ALs”), which can be measured more easily.  Some ALs are tied to ELVs, and where an AL is not exceeded, the corresponding ELV will not have been exceeded either.  Conversely, where an AL is exceeded, further consideration and assessment should be given as to whether the corresponding ELV has been exceeded.  Other ALs are not tied to ELVs, but exceedance of them may indicate the risk of potential indirect effects.

Apart from the lists in the guidance, there are other sources of information that employers can use when assessing the levels of risk, including reports of ill health by employees, equipment manufacturer data, sector or industry standards and guidelines, and trade association information.  If an employer has 5 or more employees, the assessment should be suitably recorded.  The assessment should be reviewed if there is reason to suspect it is no longer valid or if there has been a significant change in the matter to which it relates.

What are the practical implications for employers?

Critics might argue that CEMFAW represents yet another tier of bureaucracy for employers to contend with.  However, it is reckoned that the vast majority of employers will not be required to do anything more than assess the levels of EMFs to which their employees may be exposed and that, in most cases, employers will be able to do this without specialist assistance (for example, from an external consultancy).  Whilst that remains to be seen, if it is correct, then CEMFAW will have struck a fair balance between protecting employees and not over-burdening employers.

US Mine Safety and Health Administration Holds Stakeholders’ Meeting to Discuss Safety, Compliance, and Next Steps

On May 12, 2016, the US Mine Safety and Health Administration (MSHA) held a stakeholders’ meeting entitled “Improving Compliance: Reemphasizing Rules to Live By and the Exam Rule.”  The meeting discussed the current status of safety and compliance in the mining industry and future plans that MSHA has for outreach and enforcement of safety standards.  Key points of discussion included: Continue Reading

US EPA’s Great Lakes Restoration Initiative Grants for Voluntary Action a Striking Contrast to the Chesapeake Bay TMDL

iStock_000055898664_SmallUS EPA announced recently that it had awarded twenty-eight Great Lakes Restoration Initiative (GLRI) grants totaling more than $12.5 million. Portions of this federal funding will provide financial assistance to owners of farmland who voluntarily act to reduce nutrient runoff from their land. The provision of federal funding to address issues in the Great Lakes basin represents a strikingly different approach than the one presented in US EPA’s 2010 TMDL plan for the Chesapeake Bay watershed, over which the Agency only recently finished litigating. The funds provided through GLRI grants may help to curb the recent water quality decline in the Great Lakes basin and may ultimately alleviate concerns that the region will be subject to federal intervention similar to the TMDL plan for the Chesapeake Bay. Continue Reading

US Supreme Court Rules Against the Corps and in Favor of Landowners With Respect to the Reviewability of Jurisdictional Determinations, Reserving for Another Day the Full Scope of Finality under the Administrative Procedure Act

In one of the most closely watched environmental and administrative law cases this term, the US Supreme Court ruled unanimously against the government on Tuesday, May 31, 2016, affirming the Eighth Circuit’s decision allowing federal courts to review the US Army Corps of Engineers’ jurisdictional determinations. Jurisdictional determinations are decisions wherein the Corps determines whether wetlands or dry river and stream beds are subject to the “waters of the United States” regulation under the Clean Water Act and have long been problematic for landowners who disagree with the Corp’s decision. Before the Court’s decision, there was a circuit split over whether jurisdictional determinations are final agency actions and thus subject to review by the courts under the Administrative Procedure Act.

In US Army Corps of Engineers v. Hawkes Co., Inc., et al., the Corps unsuccessfully argued that a jurisdictional determination does not meet the two-prong standard for finality enunciated in Bennett v. Spear. Essentially, they attempted to argue that the second prong of Bennett creates a mandatory test and that these jurisdictional determinations—and all other similar agency actions opining on the application of law to particular facts—are generally exempt from judicial review because they do not themselves alter legal rights or impose binding legal obligations. Hawkes Co., represented by the Pacific Legal Foundation, combated against this on behalf of the landowners by arguing that the Eighth Circuit decision was correct and tracked previous administrative law decisions. The landowners were supported by 16 amici curiae , all of which sent an overarching message that landowners and developers need access to the courts in the face of possible government overreach.[1]  And no entity filed an amicus brief in support of the Corps. Continue Reading

US EPA Finalizes Oil and Gas New Source Performance Standards With Potentially Broader New Source Review Impact

With US EPA’s regulation of greenhouse gas emissions from fossil fuel–fired electric generation still hotly contested in the D.C. Circuit, US EPA is proceeding with the next step in its implementation of the White House’s Climate Action Plan by moving forward with additional greenhouse gas regulations, this time of the nation’s oil and gas infrastructure.  On May 12, 2016, the Administrator signed a suite of four rules covering new and modified sources, modifying its approach to new source review determinations for the sector, finalizing regulations covering New Source Review permitting for sources on Indian lands, and setting the stage for further regulation of existing sources under Section 111(d) of the Clean Air Act. Continue Reading

Preparing for the 2016 TSCA Chemical Data Reporting

The clock will soon begin running for companies that are required to report data under US EPA’s Chemical Data Reporting (CDR) rule on the chemical substances they manufacture and import pursuant to the Toxic Substances Control Act (TSCA). Under the rule, the reports must be submitted to US EPA between June 1 and September 30, 2016.  Entities subject to the rule must submit all data required for the current reporting cycle (which covers calendar years 2012-2015) during this four-month window or face an enforcement action by the agency.

Entities Covered

The CDR applies to a wide array of chemical manufacturers and importers, including:

  • Organic and inorganic chemical manufacturers and importers;
  • Petrochemical manufacturers, petroleum refineries;
  • Paint and coatings manufacturers;
  • Pigment and dye manufacturers;
  • Alkalies and chlorine manufacturers;
  • Ink manufacturers;
  • Fertilizer manufacturers;
  • Paper and cardboard manufacturers;
  • Iron and steel mills;
  • Nonferrous metals smelters;
  • Foundries;
  • Electronic component and semiconductor manufacturers;
  • Printed circuit manufacturers;
  • Utilities and electric power generators, and
  • Many other users, manufacturers, importers and processors of chemical substances.

Continue Reading

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