Help students learn how to prepare for an upcoming study session (or sessions) with this helpful planning template! This Study Plan: Environment and Tools worksheet will help students think about the environment they want to set and the tools and materials they want to use while studying. Designed for middle school learners, this template is a useful tool in helping students to prepare for an upcoming assessment, while also boosting confidence, study habits, and other important SEL skills!
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A 457 plan is a tax-advantaged retirement savings plan offered to employees of many state and local governments and some nonprofit organizations. Like the better-known 401(k) plan in the private sector, the 457 plan allows employees to deposit a portion of their pre-tax earnings in an account, reducing their income taxes for the year while postponing the taxes due until the money is withdrawn after they retire.
A Roth version of the 457 plan, which allows after-tax contributions, may be allowed at the employer's discretion.
There are two main types of 457 plans:
As noted, the 457 plan comes in two flavors, the 457(b) and the 457(f).
The 457(b) plan is most often offered to civil servants, police personnel, and other employees of government agencies, public services, and nonprofit organizations such as hospitals, churches, and charitable organizations.
It is similar to a 401(k). Participants set aside a percentage of their salary into a retirement account. The employees choose how their money is invested from a list of options, mostly mutual funds and annuities.
The account grows in value without being taxed over the years. When the employee retires, taxes will be due on the amount withdrawn.
Employees are allowed to contribute up to 100% of their salary, provided it does not exceed the dollar limit set for the year.
If the 457 plan does not meet statutory requirements, the assets may be subject to different rules.
As of 2022, employees can contribute up to $20,500 per year to 457 plans. This limit increases to $22,500 for 2023.
In some cases, workers are allowed to contribute even more. For example, if an employer permits catch-up contributions, workers over the age of 50 may pay in an additional $6,500 a year, making their maximum contribution limit $27,000 ($20,500 + $6,500) in 2022. The catch-up contribution increases to $7,500 for tax year 2023, making the maximum contribution limit $30,000 ($22,500 + $7,500).
Also, 457(b) plans feature a "double limit catch-up" provision. This is designed to allow participants who are nearing retirement to compensate for years in which they did not contribute to the plan but were eligible to do so.
In this case, employees who are within three years of retirement age may contribute up to $41,000 in 2022 and up to $45,000 in 2023.
The 457(b) plan has all of the advantages of a 401(k), although there are some differences.
Tax Benefits
If a traditional rather than a Roth plan is chosen, the contributions are deducted from an employee's paycheck on a pre-tax basis. That amount is subtracted from the employee's gross income, effectively lowering the person's taxes paid for that year. For example, if Alex earns $4,000 per month and contributes $700 to a 457(b) plan, Alex's taxable income for the month is $3,300.
Employees invest their contributions in their choice or choices from a selection of annuities and mutual funds.
All interest and earnings generated from year to year remain untaxed until the funds are withdrawn.
Withdrawals Without Penalty
There is one big difference between the 457(b) and other tax-advantaged retirement plans: no penalty for early withdrawals in some circumstances.
If an employee retires early or resigns from the job for any reason, the funds can be withdrawn without incurring a 10% penalty from the IRS. Early withdrawals from most retirement plans are subject to the penalty except for certain hardship reasons. (The penalty was waived for two years during the COVID-19 pandemic.)
A 457(b) account holder can take a penalty-free withdrawal without changing jobs, like a 401(k) account holder. The list of acceptable reasons, however, is limited to "unforeseeable emergencies."
Exceptions to the Rules
Early withdrawals from a 457(b) are subject to the 10% penalty if the account holder rolls the funds over from a 457 to any other tax-advantaged retirement account, such as a 401(k). This would happen if, for example, a government employee quit to take a job in the private sector.
In addition, anyone who takes money out of a retirement account early must keep in mind that any income taxes due on that money will be owed in the year that the withdrawal is taken.
One potential advantage of most tax-advantaged retirement savings plans is the employer match. An employer may choose to match some portion of an employee's contribution to the plan. An employer who matches the first 3% of the employee's contribution, for example, is presenting the employee with a 3% raise.
Employer Match Is Rare
Employers can match their employees' contributions to a 457(b) but, in practice, most don't.
If they do, the employer contribution counts toward the maximum contribution limit. This is not the case for 401(k) plans.
For instance, in 2022, if an employer contributes $10,000 to a 457(b) plan, the employee can add only $10,500 for the year until the $20,500 contribution limit is reached (except for those eligible to use the catch-up option).
Looser rules for early withdrawals without a penalty.
Early distributions allowed for participants who leave a job.
As with other retirement plans, no taxes are due until money is withdrawn.
Employer contributions count toward contribution limit the year they vest.
Employer contributions subject to vesting schedule. If the employee quits, non-vested funds are forfeited.
Limited investment choices compared to private sector plans.
The 403(b) plan, like the 457(b), is mostly available to public service employees. They are a particularly common benefit offered to public school teachers.
The 403(b) has its origins in the 1950s when it exclusively offered an annuity to participants. Participants still have the option of creating an annuity but they also can choose to invest in mutual funds.
In fact, the 403(b) has changed over the years until it closely resembles the private sector's 401(k) plan, although the investment choices offered to participants are relatively limited.
The annual contribution limits are identical to those of the 457(b) and 401(k) plans.
If you're a public employee, your employer may well offer a 457(b) or a 403(b).
Dan Stewart, CFA®
Revere Asset Management, Dallas, TX
457 plans are taxed as income similar to a 401(k) or 403(b) when distributions are taken. The only difference is there are no withdrawal penalties and that they are the only plans without early withdrawal penalties. But you also have the option of rolling the assets in an IRA rollover. This way, you can better control distributions and only take them when needed.
So if you take the entire amount as a lump sum, the entire amount is added to your income and may push you into a higher tax bracket.
With the rollover route, you could take out a little this year, and so on as needed, thus controlling your taxes better. And while it remains inside the IRA, it continues to grow tax-deferred and is protected from creditors.
The 457(b) plan is a version of the 401(k) plan that is designed for public and nonprofit workers. It helps employees save for retirement while deferring the tax bill until they retire and start withdrawing the money. (The Roth version, which is available only at the employer's discretion, takes the taxes upfront, so no taxes are usually due on withdrawals.)
The 457(f) plan is also known as a SERP for Supplemental Executive Retirement Plan. It is a retirement savings plan for only the highest-paid executives in the tax-exempt sector. They are mostly employed in hospitals, universities, and credit unions.
A 457(f) is a supplement to a 457(b). Employers make additional contributions to the employee's account, beyond the usual limits. These are negotiated by contract and amount to a deferred salary adjustment.
If the executive resigns before an established vesting period, the 457(f) contribution disappears. The plan is intended as an executive retention strategy, commonly known as "golden handcuffs."
For all intents and purposes, a 457(b) is just as good as a 401(k) plan. If you're employer is a public agency or a nonprofit, it's probably your best option for retirement savings.
Assuming you opt for a traditional plan rather than a Roth plan, you'll be lowering your taxable income from year to year while plunking that money into a long-term investment account. The money won't be taxed until you retire and start taking withdrawals.
(If it's a Roth, you'll pay the taxes up front and usually will owe no taxes on the money you deposited or the profits it earns over the years.)
On the downside, your contributions will probably not be matched by your employer. But that's just reality in the nonprofit sector, not a rule of the plan.
One advantage of a 457(b) is that you can take early withdrawals without paying a tax penalty for any "unforeseeable emergency." This isn't a good idea, since you're plundering your retirement savings, but unforeseeable emergencies do happen. And, you'll owe income tax for that year on the amount you withdraw.
The required minimum distribution (RMD) you must take is determined by an IRS worksheet. An RMD is a minimum amount that must be withdrawn from certain retirement plans, like a 457(b), each year once you reach a certain age. If you were born between 1951 and 1959, the age is 73. If you were born in 1960 or after, the age is 75. This is an increase from the previous age of 72.
The UK is the world’s fifth largest economy, importing food and other goods from all over the planet.
As the UK looks to strike trade deals with other countries when it leaves the EU, we can’t allow short-term gains to come at the expense of people and nature overseas. That's why we've been talking to the government on the need for the plan to have a global vision.
We're pleased that it includes commitments to keep the protection of species at the top of the international agenda.
The Prime Minister announced steps to tackle the plastic pollution crisis wrecking our oceans, such as extending the 5p plastic bag levy and supporting plastic-free supermarket aisles.
These are all positive steps, but they don’t go far enough fast enough.
We need to move towards an end to single-use plastics now, or our oceans will choke on litter.
On air pollution, which causes 40,000 premature deaths in the UK every year, it’s good to see a target to halve its health impacts by 2030. But we still believe the ban on petrol and diesel cars must happen sooner.
The Clean Energy Future Is Arriving Faster Than You Think
The United States is pivoting away from fossil fuels and toward wind, solar and other renewable energy, even in areas dominated by the oil and gas industries.
By David Gelles, Brad Plumer, Jim Tankersley, Jack Ewing, Leo Dominguez and
To create a project management plan, first put together a high overview of the basics of your project, including the project’s scope, schedule and budget. Next, build on those basics to write an executive summary. Then, add a project timeline, risk assessment, stakeholder chart, communication plan and resource management plan to your executive summary. Lastly, gather and incorporate stakeholders’ insights to perfect and create buy-in for your plan.
Your project’s baselines should first focus on the project’s scope, then the project’s schedule and, finally, its budget. The result should be a high overview that will inform the rest of your planning process. To complete this step, answer the following questions:
An executive summary should include a definition of your project, your project’s value proposition, including the problem your project addresses and its solution, milestones and their deliverables, scope limits―and the consequences for changing these limits―goals and financial breakdown. Use the answers to the questions posed in step one to put together your executive summary.
As the face of your project before stakeholders, your executive summary should be visually appealing and succinct. Columns and visuals should break it up to make it easy to read quickly. One great tool for creating an attractive and succinct summary is a Canva executive summary template. You can customize a template to match your brand and add your content, then either download your executive summary or share it in link form.
To begin, sign up for Canva for free, then use the search box titled “What will you design?” for “executive summary” and press “enter.” Click the appropriate template for your purposes and brand, then use the tools on the left-hand side of the enlarged template to customize its colors, text and images. Add pages by clicking the plus sign at the top right-hand corner of the template and proceed to add text and customizations to complete your summary.
The best way to plot your project’s timeline is with a Gantt chart. A Gantt chart is a visual representation of what activities you plan to begin and complete and when. These activities are usually small chunks or milestones of your completed project. They also formulate the scope of your project, helping to reduce scope creep later on. Gantt charts are often the easiest to use to plot your timeline.
It is important to note expected dependencies on your Gantt chart. A dependency happens when one activity on a timeline must be completed before team members can go on to the next one. For example, a prototype needs to be completed before a focus group analysis of the prototype can take place. Thus, these two activities are dependent. Also note independent activities that can be completed even as other activities are underway, thereby saving time.
Pro tip: An easy way to note dependencies and independent activities is via color-coding. Arrows drawn on your Gantt chart can also help to pinpoint dependencies.
While Canva does offer Gantt charts to plot your project’s timeline, there are also platforms that specialize in producing Gantt chart software. Not only can this software help you put together your Gantt chart, but it can then help you stay on track with its timeline and avoid scope creep once your project begins via task descriptions and automations. If paying for such a service isn’t in your project’s budget, you can also create a Gantt chart in Excel or Google Sheets.
Gantt chart from monday.com
With your project activities recorded on your timeline, define who will be responsible for each activity. Your plan serves as a guiding star to all stakeholders involved in your project, so it’s best to record responsible parties in an intuitive chart. Create a project team chart to show who will be involved in completing the project and for which activities each is responsible. For collaboration ease, also note who each person is accountable to and their contact information.
Canva offers organizational or team chart templates you can use to customize for the needs of your project. Search “organizational chart” using the search bar in your Canva account. Click the chart that best suits your project and brand needs. Then, use the design menu to upload pictures of your team members, customize colors and replace template text to offer the data your stakeholders need for easy collaboration during the life of your project.
An example of a Canva organizational chart template to be adapted to create a project team chart.
Your risk assessment should begin with a list of obstacles that could impact your team’s ability to complete the project on time negatively at all and with the desired quality. It should then create a plan for each risk by addressing what might trigger the risk, steps that lend to risk prevention and how to mitigate a risk should it happen. Finally, it should assign stakeholders to manage risk triggers, prevention and mitigation. Some teams use a SWOT analysis to help identify strengths, weaknesses, opportunities and threats in this stage.
To dive into each risk, answer the following questions:
As you assigned responsible parties for each project activity, you likely selected people who had expertise in the areas in which their assigned activities fall. For example, if you assigned the graphic design of a marketing project to a team member, that person is likely a graphic designer. Their expertise is invaluable in assessing graphic design risks and their prevention and mitigation steps. Lean on your team for this expertise, and then implement their suggestions.
Two key subplans you should include in your project management plan are a resource and communications management plan. Your resource sub plan should list what resources are needed to complete your project and their availability. Your communications plan should include how your team will communicate one-on-one and team-wide.
A resource subplan can be completed in project management software. You can create columns for estimated expenses and other needed resources broken down by milestones, such as raw products and talent. Other customizable resource reports are available within the software and automatically kept up to date. Wrike, for example, offers customizable reports where you can track resource availability and export reports to include in your plan.
An example of Wrike’s customizable resource reports
While it may seem inconsequential compared to your risk assessment and resource plan, poor communication is the primary reason most projects experience scope gaps and project failure, according to a PMI study. Poor communication can, therefore, derail all your other planning efforts.
As such, your communications management plan should be detailed and address what, when and how information will be shared during your project. Details should focus on what needs to be communicated and at what intervals during the project execution, stakeholders’ communication preferences, a communication schedule for virtual meetings or phone calls that occur at planned intervals, who will review tasks, to whom task completions should be reported and what platforms or tools should be used for communication purposes.
Pro tip: For best results, look at the communication tools available in your project management software. Alternatively, consider what communication-tool integrations it offers. For example, most project management software offer integrations with Slack. Using available tools within your software will allow ease of collaboration and the communication visibility your team needs to stay on the same page and on track.
The team you have chosen to own the activities on your project timeline are uniquely capable of doing so. As such, they are likely to have recommendations you might not think about to make your project more successful. Moreover, if their insights are incorporated into the plan, they are more likely to enthusiastically follow it. So, get your team together and go over the details of your plan. Learn from them and incorporate their insights.
In addition, present your plan to the end-user or client for whom you are executing the project. Make sure they agree to the project scope and its deliverables. Make their preferred changes now so you don’t have to make them later. Discuss what will happen if they change their minds later―extra fees, for example―so that scope creep does not impact your project’s successful execution, on-time completion or quality final deliverable negatively.
WASHINGTON — Federal officials this week are expected to ease water cuts for 2024 under a slightly improved outlook for the Colorado River’s health, though long-term challenges remain.
The river provides water for seven U.S. states, 29 Native American tribes and two states in Mexico. It also supports a multibillion-dollar farm industry in the West and generates hydropower used across the region. Years of overuse by farms and cities and the effects of drought worsened by climate change has meant much less water flows today through the Colorado River than in previous decades.
The U.S. government in 2021 announced cuts that hit Arizona particularly hard. Last year, those cuts grew more severe thanks to continued drought, poor precipitation and less runoff from the river’s Rocky Mountains source.
A wetter winter and conservation measures have helped Improve the river’s health a bit this summer, but experts warn a drier future is ahead.
The Bureau of Reclamation will describe the Colorado River’s status based on projected water levels at Lake Powell and Lake Mead, key reservoirs that serve as barometers of the river’s health. Officials are expected to announce cuts for next year to some basin states.
The cuts are based on previous agreements to keep Lake Mead from getting too low.
Bountiful snowfall and rain last winter pulled much of the region out of drought this spring and raised water levels at reservoirs.
State water officials expect a return to what was announced in 2021, a “Tier 1” shortage. That means Arizona would see an 18% cut from it’s total water allocation, down slightly from last year. Farmers will face the brunt of the forced cuts while cities and tribes will be spared, though some have already volunteered to cut back in exchange for federal money.
Nevada, which gets far less river water than Arizona and California, is expected to lose slightly less than it did last year. Mexico is expected to face a 5% reduction.
California has not faced any forced water cuts.
No. While the winter’s precipitation brought immediate relief, the challenges of a hotter, drier future and overuse of the river remain.
Lake Powell and Lake Mead are still only about 39% and 33% full, respectively.
“That is a little better than last year, but still extremely low. It only takes a few dry years to set us back,” said Kim Mitchell, senior water policy advisor at Western Resource Advocates, a Phoenix-based nonprofit dedicated to protecting water and land in the West.
Yes, but not immediately. This week’s announcement is just one piece of various water-savings plans already in place or being negotiated.
Earlier this year, Arizona, California and Nevada released a plan to conserve an additional 3 million acre-feet of water through 2026 in exchange for $1.2 billion from the federal government. An acre-foot of water is enough to serve 2-3 households annually. The Interior Department is expected to release its analysis of the proposal this fall.
The plan, likely be finalized in 2024, would mean cuts for California’s Imperial Irrigation District, the largest user of Colorado River water. The district, which supplies farmers who grow fruits, vegetables and feed crops, is typically spared based on senior water rights.
Some tribes and individual districts in the West that supply water to farms and cities are signing contracts to use less water in exchange for federal money.
The Gila River Indian Community in Arizona agreed in April with the U.S. government not to use some of its river water rights in return for $150 million and funding for a pipeline project. The tribe gets Colorado River water through the the same aqueduct system that delivers river water to Arizona’s major cities.
The cuts anticipated this week would not be “a big swing one way or the other in terms of on-reservation use,” said Jason Hauter, a member of the Gila River Indian Community and a tribal water attorney.
Farmers use between 70% and 80% of all water in the Colorado River system, but this week’s announcement is not expected to change much for most of them.
In August 2021, one farming district in Arizona’s Pinal County outside of Phoenix lost almost its entire Colorado River water supply. Though the river’s health is improving, the farmers are not expected to get that water back.
Instead, they have either turned to groundwater or given up — as much as half the farmland has gone unplanted in the past two years, estimated Brian Yerges, general manager of the Maricopa-Stanfield Irrigation and Drainage District, which serves the region.
Western residents are unlikely to feel the effect of this week’s announcement. In Arizona, Phoenix’s water supply didn’t diminish when the state’s was cut because other sources compensated. The nation’s fifth-largest city is supplied by the Colorado River as well as the in-state Salt and Verde rivers, with a small portion from groundwater and recycled wastewater.
Already in the Las Vegas area, ornamental lawns are banned, swimming pool sizes are limited, and almost all water inside homes is recycled. Because of that, the impact of water cuts over the past two years has been minimal. Despite last winter’s precipitation, the Southern Nevada Water Authority said it would continue with its strict conservation measures.
The Metropolitan Water District of Southern California, which supplies nearly 20 million people, lifted restrictions in March on nearly 7 million people. But that was largely because of improved conditions for rivers in Northern California that supply the district with most of its water in addition to the Colorado River.
Guidelines that dictate how Colorado River water is allocated expire in 2026.
“We have a generational set of agreements coming up,” said Bill Hasencamp, manager of Colorado River resources for the Metropolitan Water District of Southern California. “That’s where we need to focus.”
Discussions among states, tribes and the federal government about their priorities for the river after 2026 are just starting. Mexican negotiators will engage in a similar but parallel process with U.S. officials.
Negotiators say long-term discussions must consider how users will live with significantly less water in the system.
“We had a good year,” said Anne Castle, U.S. Commissioner to the Upper Colorado River Commission. “But no one expects that’s going to be the new normal. The question is, ‘What’s the plan for the future?’”
Associated Press writers Ken Ritter in Las Vegas and Amy Taxin in Orange County, California, contributed.
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When it comes to retirement planning, diversification is key. By spreading your investments across different asset classes, you can minimize risk and maximize returns. But while most people focus on stocks, bonds and mutual funds, there's another investment worth considering for your retirement strategy: gold.
Gold IRAs, in particular, are specifically designed for retirement investing, with attractive tax benefits not offered by other gold investments. By opening a gold IRA, you can enjoy these benefits and gain exposure to gold's many perks as an investment.
Learn how you can incorporate a gold IRA into your retirement plan with a free information kit.
Here's why a gold IRA can be a valuable part of your retirement plan.
There are many ways to invest in gold. Arguably one of the biggest advantages of opting for a gold IRA is the tax benefits it provides.
Depending on the type of gold IRA you choose, you can enjoy tax benefits either now or in the future. A traditional gold IRA allows you to contribute pre-tax dollars, and your money is taxed when you withdraw it. A Roth gold IRA taxes your contributions when you make them, and your withdrawals are tax-free.
By considering your current and future financial needs, you can select the IRA type that will allow you to keep the most money in your pocket.
High-growth assets like stocks can be extremely unpredictable. When the markets dip, investors with a lot of money in these assets can lose significant amounts of money.
Gold, on the other hand, is not correlated to the stock market. In fact, when stocks are down, gold usually performs well, which can help offset any losses you may experience in other investments. By keeping about 5% to 10% of your portfolio in gold, you can safeguard your retirement savings from risk while allocating room to higher-risk, higher-reward assets.
Inflation can rapidly erode the value of your retirement savings. Gold is a proven hedge against inflation because, unlike paper currency, it can't be devalued by overproduction. It's an asset, currency and material and is used in everything from jewelry to electronics, so it's always in demand. And when investors seek to preserve their purchasing power from inflation, the increased demand drives prices up, making gold investments more valuable.
If you're concerned about the long-term impact of inflation on your retirement savings, a gold IRA can offer some protection and peace of mind.
Request your free investors kit today to find out if a gold IRA is right for you.
Gold has historically performed well in times of economic turmoil and geopolitical uncertainty, delivering steady, reliable returns as other investments falter. In fact, central banks hold gold specifically because they trust its stability and safety.
In a world where there's always worrisome news of some type, gold can help your portfolio weather the storms that will inevitably arise between now and your retirement date.
Adding gold to your retirement plan is a wise move for many reasons. It delivers unique tax benefits, protects your money from market volatility and inflation and provides a safe haven from economic ups and downs. These things are crucial when it comes to an investment as important as your retirement.
Of course, as with any investment, you should do your own research and speak with a financial advisor to determine the best way to incorporate a gold IRA into your portfolio. Done right, you can reap the full rewards of this valuable retirement account.
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The world’s rivers are full of drugs — and it’s making the world sick.
A leaked draft of the European Commission’s revision of the bloc’s pharmaceutical rules shows the EU is looking to crack down on pollution from medicines by ratcheting up environmental requirements. But its plans are facing internal resistance, pushback from industry and questions over methodology — and it remains to be seen which measures make the cut when the proposal is finally published on April 26.
It’s not a trivial problem. One study published last year monitored over 1,000 sampling sites along 258 rivers in 104 countries across all continents for active pharmaceutical ingredients. Only an indigenous village in Venezuela — where modern medicines aren’t used — and Iceland were unscathed.
While not immediately lethal, drug-laced rivers harm wildlife, such as fish, frogs and birds, as the chemicals can alter their growth, reproduction and behavior.
And when antibiotics go into waterways, it can increase bacterial resistance to these lifesaving medicines, harming people's ability to fight common infections. The U.N. estimates that up to 10 million deaths could be caused by superbugs by 2050, matching the annual death toll of cancer.
In its draft plans, the Commission wants to allow the EU’s drug regulator to turn down medicines approval on environmental grounds, and require drug companies to measure the environmental impact of their production process.
It would be a step-change in attempts to curb pharmaceutical-linked pollution.
For environmental activists, stricter standards can’t come soon enough.
Scientists in exact years have warned that pharmaceuticals constitute a “weakly regulated global environmental risk.” And a February U.N. Environmental Program report on antimicrobial resistance (AMR) found that “the pharmaceutical industry is considered largely an unregulated sector in terms of environmental pollution.”
“I don't think that [pharmaceutical pollution] has been taken yet seriously enough [by policymakers] — it should be taken more seriously,” said Mirella Miettinen, a senior researcher in environmental law at the University of Eastern Finland’s law school. “And quite fast hopefully.”
But the new rules are not a sure thing. A document seen by POLITICO showed that the proposed changes have already been caught in an internal tug-of-war, with the Commission’s environment department pushing for a greater focus on environmental risks and the industry department skeptical of more stringent rules.
Meanwhile, the pharmaceutical industry has already pushed back against the leaked draft.
Hubertus Cranz, director general of the German Medicines Manufacturers’ Association, called the proposals “very problematic,” saying that while his group is committed to objectives around environmental sustainability, the industry is really “struggling a lot with the administrative burden.”
Linking environmental risk assessments to drug approvals risks detracting from drug efficacy and safety — the main metrics by which to judge new drugs until now, he added.
Under current rules for drug approvals, pharmaceutical companies have to submit an environmental risk assessment (ERA) detailing how toxic the chemicals in a new medicine are, how long they linger in the environment, and what their impact is on plants, animals and microbes.
They’re also required to estimate how much of these ingredients will leak into the environment through normal use and disposal, and can be asked to put in place mitigation measures if they exceed certain levels.
But Laure Herold, a communications official for the European Medicines Agency (EMA), said that while companies are required to submit an environmental risk assessment, and would be marked down for a missing one, marketing authorization can’t currently be denied on the basis of an “incomplete ERA.”
An analysis by the Pharmaceutical Journal found that one in five new medicines approved by the EMA in 2021 were submitted without all environmental data. And drugs approved before October 30, 2005 were never required to carry out an assessment.
“So far, it’s pretty meaningless, and we’re really hoping that with this new legislation that is going to change,” said Dorothea Baltruks, a research associate at the Centre for Planetary Health Policy, a German think tank.
Under the proposed rules, drug companies will need to estimate — for the first time — the environmental impact of their manufacturing process, beyond use and disposal of the medicines. They will be asked to propose risk mitigation measures to reduce the impact of manufacturing wastewater in the environment. And, crucially, the EMA will be able to turn down a drug’s approval if it doesn’t meet certain standards.
Perhaps a bigger problem is that there’s disagreement about how risks are actually assessed and what the permissible levels of chemicals are — something it will be up to regulators to decide.
Herold said the risk assessments are based on worst-case scenarios of environmental exposure, and that “only a very small minority of human medicinal products have been shown to constitute a potential threat to the environment.”
But Alistair Boxall, one of the co-authors of the study on pharmaceutical pollution in rivers, takes issue with the “underlying science” of the current risk assessments, saying they’re not sensitive enough to calculate a drug’s pollution footprint correctly.
The anti-inflammatory drug Diclofenac, for example, is a widely used over-the-counter medicine that is known to pose a threat to certain animals and plants — it gets flushed into wastewater systems after digestion. But based on the standard studies necessary to conduct an environmental risk assessment under EU law, the data suggests the drug holds little danger for rivers.
“I think some of the models we use are probably not giving necessarily the right answers,” Boxall said.
What's more, while the proposed risk assessments will — for the first time — consider the impact of antibiotics production on AMR, more research is needed before policymakers can introduce binding targets, according to one of the authors of the U.N. report on AMR in the environment.
Too stringent standards could drive up prices and negatively impact antibiotic access, but it’s also not yet clear what the effects of persistent lower levels of antibiotic pollution are.
“We know that, in the long run, releasing chemicals into the environment isn't a good thing,” said David Graham, professor of ecosystems engineering at Newcastle University. But “it's very much a matter of almost professional opinion, as to the level and extent of effects you might see.”