Company Safety Data Sheets on New Chemicals Frequently Lack the Worker Protections EPA Claims They Include

Insights + Opinion

By Richard Denison

Readers of this blog know how concerned EDF is over the Trump EPA's approval of many dozens of new chemicals based on its mere "expectation" that workers across supply chains will always employ personal protective equipment (PPE) just because it is recommended in the manufacturer's non-binding safety data sheet (SDS).

The typical course has been for EPA to identify risks to workers from a new chemical it is reviewing under the Toxic Substances Control Act (TSCA), but then — instead of issuing an order imposing binding conditions on the chemical's entry onto the market, as TSCA requires — to find that the chemical is "not likely to present an unreasonable risk" and impose no conditions whatsoever on its manufacturer. This sleight of hand is pulled off by EPA stating that it:

expects employers will require and workers will use appropriate personal protective equipment (PPE) … consistent with the Safety Data Sheet prepared by the new chemical submitter, in a manner adequate to protect them.

We have detailed earlier the myriad ways in which this approach strays from the law, is bad policy and won't protect workers. But here's yet another gaping problem: When we are able to look at the actual SDSs — that is, when EPA has made them available and when they are not totally redacted — we are frequently finding that the specific PPE that EPA claims to be specified in the SDSs — and that EPA asserts is sufficient to protect all workers handling the chemical — is not in the SDSs.

EDF recently examined the SDSs for each of five new chemicals where EPA has declared them "not likely to present an unreasonable risk" and included the language I cited above. EPA has also included the five in a proposed Significant New Use Rule (SNUR) that would require companies to notify EPA if they intend to use a chemical in a particular manner that EPA has defined as a "significant new use." On Monday, EDF filed extensive critical comments on those proposed SNURs.

The reason we are focusing here on these chemicals is because, by law, EPA had to establish a rulemaking docket for the SNUR and place in that docket certain supporting documents pertaining to each new chemical. Among those documents is (supposed to be) the chemical's corresponding SDS.

Unfortunately, for two of the five chemicals (identified as P-18-0073 and P-19-0010, because the companies claimed their actual identities to be confidential), EPA failed to provide a copy of the SDS in its docket even though it is part of the documentation the company was required to submit to EPA. For another of the five (P-17-0239), the copy of the SDS EPA included in the docket is totally redacted — even though much if not all of its content comprises health and safety information not eligible for confidential business information (CBI) protection under TSCA and, for the remainder, there is no evidence EPA has reviewed and approved any CBI claims the company asserted for the SDS.

That leaves us with the SDSs for the remaining two cases (P-18-0048and P-18-0122), which are unredacted. Now we can compare what they specify by way of PPE to the specific PPE that EPA relied on in determining these chemicals are "not likely to present an unreasonable risk."

P-18-0048: Here is what the "not likely" determination document for P-18-0048 states:

Risks to workers: Reproductive toxicity via dermal exposure; corrosion to all tissues via dermal and inhalation exposures.

PPE EPA relies on: EPA identifies as "appropriate PPE" the use of "impervious gloves and a respirator." EPA goes on to state:

EPA expects that employers will require and workers will use appropriate personal protective equipment, including dermal and respiratory protection with an Assigned Protection Factor [APF] of 50, consistent with the Safety Data Sheet submitted with the PMN [premanufacture notice], in a manner adequate to protect them. (p. 6, emphasis added)

The associated SDS does recommend wearing "protective gloves," "suitable protective equipment," and "appropriate chemical resistant gloves." Its only reference to respiratory protection, however, is this:

[I]n the case of insufficient ventilation, wear suitable respiratory equipment.

Nowhere does the SDS specify use of a respirator with an APF of 50. The SDS is clearly not consistent with EPA's own description of it.

P-18-0122: Here is what the "not likely" determination document for P-18-0122 states:

Risks to workers: Lung toxicity via inhalation; irritation to skin, eyes, lung and GI tract.

PPE EPA relies on:

Risks will be mitigated if exposures are controlled by the use of appropriate PPE, including respiratory protection with an APF of 10. Risks could not be quantified for irritation hazards, but appropriate PPE, including impervious gloves and protective eye wear, would mitigate concerns. EPA expects that employers will require and workers will use appropriate personal protective equipment (i.e., impervious gloves, protective eye wear, and a respirator), consistent with the Safety Data Sheet prepared by the PMN submitter, in a manner adequate to protect them. (pp. 5-6, emphases added)

While the corresponding SDS does recommend certain types of gloves and safety glasses, it specifically states:

Other protective equipment is not generally required under normal working conditions.

The only mention of use of a respirator anywhere in the SDS is where an OSHA regulatory workplace standard is exceeded – which is clearly not the case here, as no such standards exist for the new chemical. Nowhere does the SDS specify use of a respirator with an APF of 10. Here again, the SDS is clearly not consistent with EPA's own description of it.

Other Recent Cases Found

This finding spurred us to look further at other "not likely" determinations and the corresponding SDSs. This is slower-going, because there is no electronically accessible docket. That's not only because EPA has not proposed a SNUR for other new chemicals to which it recently gave the green light; it's also because EPA has failed to comply with its own regulations requiring it to provide electronic access to all new chemical submissions it receives.

As we have described elsewhere, EDF has had no choice but to request the "public files" for these chemicals through EPA's Docket Center, which can take several weeks (they come by snail mail on a CD-ROM).

I looked at a number of recent new chemicals EPA has green-lighted for which we have received public files. In one case no SDS was provided in the public file, while in two others the SDS was there but again totally redacted. In some of the remaining cases the SDS recommended PPE that matched that EPA described in its "not likely" document, or at least came close.

But in other cases, there was not a match. Here are two examples:

P-19-0021/22: Here is what the "not likely" determination document for P-19-0021 and P-19-0022 states:

Risks to workers: Lung overload via inhalation.

PPE EPA relies on:

Risks will be mitigated if exposures are controlled by the use of appropriate PPE, including a respirator with APF of 50. EPA expects that workers will use appropriate PPE consistent with the SDS prepared by the PMN submitter, in a manner adequate to protect them. (p. 5, emphases added)

The associated SDS makes only this reference to respiratory protection:

Respiratory protection: Mist respirator, include single use respirator

Nowhere does the SDS specify use of a respirator with an APF of 50. The SDS is clearly not consistent with EPA's own description of it.

P-18-0212: Here is what the "not likely" determination document for P-18-0212 states:

Risks to workers: Systemic effects via inhalation exposure; portal of entry/contact effects to the eyes, lungs and skin following ocular, inhalation, and dermal exposures

PPE EPA relies on:

The risks and hazards identified will be mitigated if exposures are controlled by the use of appropriate PPE, including impervious gloves, respirators with an APF of at least 10, and eye protection. EPA expects that workers will use appropriate personal protective equipment (i.e., impervious gloves, respirator with an APF of at least 10, and eye protection), consistent with the Safety Data Sheet submitted with the PMN, in a manner adequate to protect them. (p. 5, emphases added)

The associated SDS makes this reference to respiratory protection:

Respiratory Protection: For operations where inhalation exposure can occur use an approved respirator. Recommendations are listed below. Other protective respiratory equipment may be used based on user's own risk assessment. Recommended respirators include those certified by NIOSH.
Recommended: Full Face Mask with a combination particulate/organic vapor cartridge.

Nowhere does the SDS specify use of a respirator with an APF of 10. The SDS is clearly not consistent with EPA's own description of it.


In each of these cases, EPA identified a particular type of respirator as necessary for its finding that the chemical is not likely to present an unreasonable risk, and in each case, EPA asserted that the corresponding SDS specified that type of equipment. But in fact, in each case, the SDS does not specify that type of respirator. EPA's decisions run counter to the actual evidence before the agency, and EPA has actually mischaracterized that evidence. That amounts to arbitrary decision-making. Practically speaking, this mismatch means that workers could follow the SDS to a T and be using a respirator that is not sufficient to protect them against the chemical's identified risks.

As we have noted before, EPA's reliance on SDS-recommended PPE flouts the law and falls vastly short of what TSCA requires EPA to do to protect workers. Amended TSCA requires EPA to issue binding orders to mitigate identified risks posed to workers by new chemicals, which it has identified in each of the cases we cite above. EPA's mere "expectation" that PPE will universally be available, used and effective is wholly insufficient to address the identified risks. The recommendations in an SDS are not binding on employers, neither on manufacturers nor on other companies downstream in supply chains. Failure to always use PPE or for it always to be effective is clearly reasonably foreseeable, and EPA is required to mitigate risks from "reasonably foreseen conditions of use" of a new chemical. PPE is the option of last resort under the longstanding Industrial Hygiene Hierarchy of Controls adopted by OSHA and embraced by the industrial hygiene community. Reliance on expected use of PPE shifts the burden of protection off of EPA and employers and onto the backs of workers.

Now, we find that even the PPE EPA identifies as necessary to be in an SDS in order to determine that a new chemical is not likely to present an unreasonable risk is frequently absent from the SDS. Even under its own flawed theories, EPA is utterly failing to protect workers from the risks of these chemicals.

How much farther under the bus will the Trump EPA throw American workers?

Richard Denison is a lead senior scientist with Environmental Defense Fund.

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Ola Elvestrun, Norway's environment minister, announced Thursday that it is freezing its contributions to the Amazon Fund, and will no longer be transferring €300 million ($33.2 million) to Brazil. In a press release, the Norwegian embassy in Brazil stated:

Given the present circumstances, Norway does not have either the legal or the technical basis for making its annual contribution to the Amazon Fund.

Brazilian President Jair Bolsonaro reacted with sarcasm to Norway's decision, which had been widely expected. After an official event, he commented: "Isn't Norway the country that kills whales at the North Pole? Doesn't it also produce oil? It has no basis for telling us what to do. It should give the money to Angela Merkel [the German Chancellor] to reforest Germany."

According to its website, the Amazon Fund is a "REDD+ mechanism created to raise donations for non-reimbursable investments in efforts to prevent, monitor and combat deforestation, as well as to promote the preservation and sustainable use in the Brazilian Amazon." The bulk of funding comes from Norway and Germany.

The annual transfer of funds from developed world donors to the Amazon Fund depends on a report from the Fund's technical committee. This committee meets after the National Institute of Space Research, which gathers official Amazon deforestation data, publishes its annual report with the definitive figures for deforestation in the previous year.

But this year the Amazon Fund's technical committee, along with its steering committee, COFA, were abolished by the Bolsonaro government on 11 April as part of a sweeping move to dissolve some 600 bodies, most of which had NGO involvement. The Bolsonaro government views NGO work in Brazil as a conspiracy to undermine Brazil's sovereignty.

The Brazilian government then demanded far-reaching changes in the way the fund is managed, as documented in a previous article. As a result, the Amazon Fund's technical committee has been unable to meet; Norway says it therefore cannot continue making donations without a favorable report from the committee.

Archer Daniels Midland soy silos in Mato Grosso along the BR-163 highway, where Amazon rainforest has largely been replaced by soy destined for the EU, UK, China and other international markets.

Thaís Borges.

An Uncertain Future

The Amazon Fund was announced during the 2007 United Nations Climate Change Conference in Bali, during a period when environmentalists were alarmed at the rocketing rate of deforestation in the Brazilian Amazon. It was created as a way of encouraging Brazil to continue bringing down the rate of forest conversion to pastures and croplands.

Government agencies, such as IBAMA, Brazil's environmental agency, and NGOs shared Amazon Fund donations. IBAMA used the money primarily to enforce deforestation laws, while the NGOs oversaw projects to support sustainable communities and livelihoods in the Amazon.

There has been some controversy as to whether the Fund has actually achieved its goals: in the three years before the deal, the rate of deforestation fell dramatically but, after money from the Fund started pouring into the Amazon, the rate remained fairly stationary until 2014, when it began to rise once again. But, in general, the international donors have been pleased with the Fund's performance, and until the Bolsonaro government came to office, the program was expected to continue indefinitely.

Norway has been the main donor (94 percent) to the Amazon Fund, followed by Germany (5 percent), and Brazil's state-owned oil company, Petrobrás (1 percent). Over the past 11 years, the Norwegians have made, by far, the biggest contribution: R$3.2 billion ($855 million) out of the total of R$3.4 billion ($903 million).

Up till now the Fund has approved 103 projects, with the dispersal of R$1.8 billion ($478 million). These projects will not be affected by Norway's funding freeze because the donors have already provided the funding and the Brazilian Development Bank is contractually obliged to disburse the money until the end of the projects. But there are another 54 projects, currently being analyzed, whose future is far less secure.

One of the projects left stranded by the dissolution of the Fund's committees is Projeto Frutificar, which should be a three-year project, with a budget of R$29 million ($7.3 million), for the production of açai and cacao by 1,000 small-scale farmers in the states of Amapá and Pará. The project was drawn up by the Brazilian NGO IPAM (Institute of Environmental research in Amazonia).

Paulo Moutinho, an IPAM researcher, told Globo newspaper: "Our program was ready to go when the [Brazilian] government asked for changes in the Fund. It's now stuck in the BNDES. Without funding from Norway, we don't know what will happen to it."

Norway is not the only European nation to be reconsidering the way it funds environmental projects in Brazil. Germany has many environmental projects in the Latin American country, apart from its small contribution to the Amazon Fund, and is deeply concerned about the way the rate of deforestation has been soaring this year.

The German environment ministry told Mongabay that its minister, Svenja Schulze, had decided to put financial support for forest and biodiversity projects in Brazil on hold, with €35 million ($39 million) for various projects now frozen.

The ministry explained why: "The Brazilian government's policy in the Amazon raises doubts whether a consistent reduction in deforestation rates is still being pursued. Only when clarity is restored, can project collaboration be continued."

Bauxite mines in Paragominas, Brazil. The Bolsonaro administration is urging new laws that would allow large-scale mining within Brazil's indigenous reserves.

Hydro / Halvor Molland / Flickr

Alternative Amazon Funding

Although there will certainly be disruption in the short-term as a result of the paralysis in the Amazon Fund, the governors of Brazil's Amazon states, which rely on international funding for their environmental projects, are already scrambling to create alternative channels.

In a press release issued yesterday Helder Barbalho, the governor of Pará, the state with the highest number of projects financed by the Fund, said that he will do all he can to maintain and increase his state partnership with Norway.

Barbalho had announced earlier that his state would be receiving €12.5 million ($11.1 million) to run deforestation monitoring centers in five regions of Pará. Barbalho said: "The state governments' monitoring systems are recording a high level of deforestation in Pará, as in the other Amazon states. The money will be made available to those who want to help [the Pará government reduce deforestation] without this being seen as international intervention."

Amazonas state has funding partnerships with Germany and is negotiating deals with France. "I am talking with countries, mainly European, that are interested in investing in projects in the Amazon," said Amazonas governor Wilson Miranda Lima. "It is important to look at Amazônia, not only from the point of view of conservation, but also — and this is even more important — from the point of view of its citizens. It's impossible to preserve Amazônia if its inhabitants are poor."

Signing of the EU-Mercusor Latin American trading agreement earlier this year. The pact still needs to be ratified.

Council of Hemispheric Affairs

Looming International Difficulties

The Bolsonaro government's perceived reluctance to take effective measures to curb deforestation may in the longer-term lead to a far more serious problem than the paralysis of the Amazon Fund.

In June, the European Union and Mercosur, the South American trade bloc, reached an agreement to create the largest trading bloc in the world. If all goes ahead as planned, the pact would account for a quarter of the world's economy, involving 780 million people, and remove import tariffs on 90 percent of the goods traded between the two blocs. The Brazilian government has predicted that the deal will lead to an increase of almost $100 billion in Brazilian exports, particularly agricultural products, by 2035.

But the huge surge this year in Amazon deforestation is leading some European countries to think twice about ratifying the deal. In an interview with Mongabay, the German environment ministry made it very clear that Germany is very worried about events in the Amazon: "We are deeply concerned given the pace of destruction in Brazil … The Amazon Forest is vital for the atmospheric circulation and considered as one of the tipping points of the climate system."

The ministry stated that, for the trade deal to go ahead, Brazil must carry out its commitment under the Paris Climate agreement to reduce its greenhouse gas emissions by 43 percent below the 2005 level by 2030. The German environment ministry said: If the trade deal is to go ahead, "It is necessary that Brazil is effectively implementing its climate change objectives adopted under the [Paris] Agreement. It is precisely this commitment that is expressly confirmed in the text of the EU-Mercosur Free Trade Agreement."

Blairo Maggi, Brazil agriculture minister under the Temer administration, and a major shareholder in Amaggi, the largest Brazilian-owned commodities trading company, has said very little in public since Bolsonaro came to power; he's been "in a voluntary retreat," as he puts it. But Maggi is so concerned about the damage Bolsonaro's off the cuff remarks and policies are doing to international relationships he decided to speak out earlier this week.

Former Brazil Agriculture Minister Blairo Maggi, who has broken a self-imposed silence to criticize the Bolsonaro government, saying that its rhetoric and policies could threaten Brazil's international commodities trade.

Senado Federal / Visualhunt / CC BY

Maggi, a ruralista who strongly supports agribusiness, told the newspaper, Valor Econômico, that, even if the European Union doesn't get to the point of tearing up a deal that has taken 20 years to negotiate, there could be long delays. "These environmental confusions could create a situation in which the EU says that Brazil isn't sticking to the rules." Maggi speculated. "France doesn't want the deal and perhaps it is taking advantage of the situation to tear it up. Or the deal could take much longer to ratify — three, five years."

Such a delay could have severe repercussions for Brazil's struggling economy which relies heavily on its commodities trade with the EU. Analysists say that Bolsonaro's fears over such an outcome could be one reason for his recently announced October meeting with Chinese President Xi Jinping, another key trading partner.

Maggi is worried about another, even more alarming, potential consequence of Bolsonaro's failure to stem illegal deforestation — Brazil could be hit by a boycott by its foreign customers. "I don't buy this idea that the world needs Brazil … We are only a player and, worse still, replaceable." Maggi warns, "As an exporter, I'm telling you: things are getting very difficult. Brazil has been saying for years that it is possible to produce and preserve, but with this [Bolsonaro administration] rhetoric, we are going back to square one … We could find markets closed to us."

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