Pending EPA and California efforts to regulate nanoscale materials are drawing major concerns from industry. Several groups are fighting EPA's plan to require “adverse effects” reporting on nanomaterials used in pesticides and requirements to identify nanoscale ingredients on pesticide labels. Meanwhile, industry officials in California are urging major revisions to a report recommending sweeping state rules for the materials.

EPA is moving forward with several long-awaited chemical control measures, including floating a determination to regulate the rocket fuel ingredient perchlorate under its drinking water rules and proposing a draft assessment of the risks posed by chromium 6.

After years of delay, EPA is launching a rulemaking to clarify when pesticides qualify for a regulatory exemption for “minimum risk” substances – a rule that specialty chemical manufacturers have long sought.

In This Issue . . .

Industry Asks OMB To Scuttle Strict New EPA Nanoscale Pesticide Policies
Chemical industry officials are urging the White House's regulatory affairs office to halt EPA's pending policy for requiring "adverse effects" reporting about nanoscale pesticide ingredients, calls that are being heightened by recent agency suggestions that it plans to require industry to identify nanoscale ingredients on pesticide labels.

Industry Urges Major Revisions To California Nanotech Regulation Report
Nanotechnology industry officials are urging California's health hazard office and University of California scientists to make significant revisions to a report laying out sweeping recommendations for state regulation of nanomaterials, fearing the report as written could create "confusion" about how to regulate nanotech.

California Nano Risk Data Reporting Plan Could Serve As National Model
California's toxics department has unveiled plans to gather risk data on six candidate nanomaterials by requesting manufacturers to submit environmental and other data on various so-called nano metal oxides used in consumer products, a move that could offer a model for other states and EPA on assessing nanomaterials' risks.

In Loss For Industry, EPA Decides To Regulate Perchlorate Under SDWA
EPA has decided to regulate the rocket fuel ingredient perchlorate under the Safe Drinking Water Act (SDWA), reversing a controversial Bush administration decision not to regulate after finding that setting a drinking water standard would provide a meaningful opportunity to reduce risks posed by the ubiquitous chemical, according to a federal source.

OMB, Industry Urge EPA To Delay Cancer-Risk Review For Chromium 6
The White House Office of Management and Budget (OMB) and affected industry groups are urging EPA to delay its just issued draft risk assessment of the metal hexavalent chromium (Cr6), which proposes to significantly strengthen the agency's current assessment, until additional research and analysis of the metal's risks are completed.

EPA Plans Rule To Clarify FIFRA Waiver For 'Minimum Risk' Pesticides
EPA is launching a long-awaited rulemaking on its "minimum risk" pesticides exemption, which will establish criteria for pesticides with certain types of safe ingredients that are exempted from federal regulation under the Federal Insecticide, Rodenticide, and Fungicide Act (FIFRA), which controls pesticide sale and use.

EPA Proposes Tightening Protections For Human Volunteers In Pesticides Tests
EPA has sent for White House review a proposal to strengthen the agency's protections for human subjects taking part in pesticide exposure tests, a rulemaking required under a court settlement with environmentalists seeking strict ethical and scientific standards for such tests.

Industry Seeks More Time To Comment On EPA Chemicals Reporting Rule
The American Chemistry Council (ACC) is asking EPA to extend by 30 days the public comment period on the agency's proposal to modify a key toxics reporting rule, saying ACC needs more time to address major issues including whether chemical processors should be required to provide processing and use data to EPA under the rule.

Industry Asks OMB To Scuttle Strict New EPA Nanoscale Pesticide Policies

Chemical industry officials are urging the White House's regulatory affairs office to halt EPA's pending policy for requiring "adverse effects" reporting about nanoscale pesticide ingredients, calls that are being heightened by recent agency suggestions that it plans to require industry to identify nanoscale ingredients on pesticide labels.

At a series of recent meetings with the White House Office of Management & Budget's (OMB) Office of Information & Regulatory Affairs (OIRA), industry officials have reiterated long-standing concerns that EPA's policy may be unlawful and could demonize the emerging technology. Industry groups represented at the meetings include the American Chemistry Council (ACC), CropLife America -- which represents pesticide manufacturers -- and the Silver Nanotechnology Working Group (SNWG).

"Until EPA fully considers and understands the job losses, economic burden, negative impact on green chemistry and innovation, and the stigma to nanotechnology development and the chemical industry in general, the proposed policy should be indefinitely delayed or completely rescinded," the SNWG says in a presentation from an Aug. 19 meeting.

The group says the EPA policy could lead to the U.S. nanomaterials industry being "indefinitely trapped in a bureaucratic loop resulting in continued job losses, compromising U.S. leadership in nanomaterials innovation."

The meetings have also been attended by representatives of EPA, the White House Office of Science & Technology Policy, the U.S. Department of Agriculture and the U.S. Trade Representative -- highlighting previous industry efforts to take their concerns about the pending EPA policy to other agencies that might have objections.

EPA intends to use section 6(a)(2) of the Federal Insecticide, Fungicide & Rodenticide Act (FIFRA), which dictates that pesticide registrants must submit any information concerning "adverse effects" of their products, to require registrants to report the inclusion of nanoscale ingredients.

Section 6(a)(2) of FIFRA "requires pesticide product registrants to submit adverse effects information about their products to the EPA," and agency officials say the requirement is needed to determine the potential effects of nanomaterials on human health and the environment. EPA July 30 sent a draft notice detailing its plans to OMB for review.

Promising Technologies

But industry groups have long raised concerns with the use of section 6(a)2 of FIFRA, fearing that it could stigmatize promising technologies. Industry officials are instead suggesting that EPA rely on alternative FIFRA authorities, contained in provisions of the law governing product registrations, that would allow EPA to require the data without stigmatizing the products.

But EPA officials have told industry that the alternative approaches are more burdensome for both industry and regulators, one industry source says.

Industry concerns about "adverse effects" reporting are further compounded by EPA suggestions at a recent meeting that the agency may require registrants to identify nanoscale ingredients in pesticides on the products' labels.

Jennifer McLain, an official with the agency's Office of Pesticide Programs (OPP), told the State FIFRA Issue Research & Evaluation Group Sept. 20 that "nano-products will be labeled [in the] same way as other pesticide products," and nanoscale ingredients in the pesticides would be "listed as 'nano-x'" on the label, according to her presentation.

But the industry source says such labeling requirement could be "another stigma" for nanomaterials in addition to the adverse effects reporting, though industry is still seeking more details about how the labeling would work and how EPA will pursue the changes.

In a Sept. 29 memorandum on the presentation, law firm Bergeson & Campbell mentions a number of "thorny issues" raised by the labeling policy. "What exactly is subject to labeling?" the memo asks. "Will the presence of any nanoscale material in a formulation trigger a nano label? How will confidentiality issues be addressed?"

In addition to concerns from SNWG, representatives of the ACC and CropLife also raised concerns at a Sept. 8 meeting with OIRA officials about the legality of EPA pursuing the new policy without a notice-and-comment rulemaking; the lack of other opportunities for public comment and discussion; and why EPA does not use authority under FIFRA section 3(c)(2)(b) to collect the information that is seen by industry as preferable to section 6(a)(2).

The SNWG presentation says that 6(a)(2) reporting "was meant to be a post-registration check on registration decisions by requiring registrants to report to EPA additional factual information about unreasonable adverse effects," adding that the authority was designed to update risk assessments in light of "tangible evidence."

"The planned policy would require the presence of a nanomaterial in a registered pesticide to be reported under the 'unreasonable adverse effect' provision though EPA acknowledges that there is no nexus to risk," the group argues. "Invoking 6(a) 2 is not the proper method of learning additional information about a registered product when no adverse effects have been found and it is not supposed to be used for pending registrations."

Nanoscale Ingredients

In the SNWG presentation, the officials recommend that EPA use the FIFRA pesticide reregistration process authorized in section 3 to gain information about nanoscale ingredients in pesticides and then use this data in agency risk assessments of the substances and in the development of other policies.

The group says the FIFRA registration process gives EPA the authority to prohibit the use of nanomaterials in pesticides, as well as requiring manufactures to report adverse effects seen after the substances are registered. The group says EPA could also modify FIFRA to collect the information without the "adverse effects" label.

At both meetings, industry officials also raised concerns about how the adverse effects reporting requirement could end up "demonizing " the use of nanomaterials and lead to "diminished marketability" for the products. Additional data requirements could stifle innovation in the nanomaterials industry, the SNWG presentation says, warning that one member company could go out of business under the new reporting policy. "This will snowball as more and more nanomaterial companies and investors become discouraged from the uncertainty and cloud of adverse perception surrounding nanopesticides and nanomaterials," the group says in the presentation.

Further, the industry source says the section 6(a)(2) reporting could have a "perverse result" of encouraging some in the downstream chain to not look for nanoscale materials in their products to avoid the reporting.

SNWG further suggests more study of how nanoscale materials contribute to "green chemistry," including an analysis of "the relative risks and benefits to the implementing of the regulations," the presentation says.

At the September meeting, the ACC and CropLife further questioned the lack of a definition for nanomaterials that has been vetted throughout the federal government, and among other key groups. The industry source says there are different definitions used by international groups, government agencies in California, and even among different offices in EPA.

The agency's policy is also expected to include OPP's new "working definition" of nanomaterials as ingredients that contain particles intentionally produced to have at least one dimension ranging in size between approximately 1 and 100 nanometers.

EPA officials have indicated that any pesticide containing a nanoscale material as either an active or inert ingredient would be considered new and therefore subject to more agency scrutiny, meaning the widely used ingredient nanosilver would be considered new although silver is already registered as a pesticide ingredient. -- Aaron Lovell

top of page

Industry Urges Major Revisions To California Nanotech Regulation Report

Nanotechnology industry officials are urging California's health hazard office and University of California scientists to make significant revisions to a report laying out sweeping recommendations for state regulation of nanomaterials, fearing the report as written could create "confusion" about how to regulate nanotech.

Industry also claims that the report fails to acknowledge critical progress that state regulators and industry have made to date in collecting environmental data on nanotechnology. Industry and activists are closely watching the report because it is one of the first outlining specific regulatory actions California should take on nanotechnology, and could be potentially seen as a model for other states or the federal government in regulating nanomaterials.

Nanotechnology refers to the manipulation of individual atoms and molecules to create products or devices with novel uses or properties. Worldwide scientists and stakeholders continue to review scientific data to determine the as-yet-unknown potential benefits and risks to human health from nanotechnologies. Nanomaterials are increasingly being used in consumer products, such as electronics, sunscreen and medicine.

University of California-San Francisco (UCSF) earlier this year released a report entitled "A Nanotechnology Policy Framework for California." The state's Office of Environmental Health Hazard Assessment (OEHHA) commissioned UCSF to produce the report, which makes a number of recommendations for OEHHA and other California policymakers, including calling for assessments of the risks of nanomaterials.

The draft report's sweeping recommendations for OEHHA and the California Department of Toxic Substances Control (DTSC) include incorporating nanomaterials into existing regulatory programs. But the release of the report earlier this year caught industry officials and other observers by surprise.

In an Aug. 13 letter to OEHHA, California EPA and UCSF officials, representatives of the California Nano Industry Network argue that despite the report's findings, there has been "an unprecedented degree of collaboration over the past 5-6 years in addressing precisely those needs spoken to in the draft -- collaboration among U.S. agencies, among national governments, and collaboration between industry, [the environmental] community and governments."

The breadth and depth of those collaborative efforts and their progress "is simply not given due recognition in the draft," the industry argues.

The draft report also raised the additional question of coordination among Cal/EPA agencies, the letter states, especially since DTSC has been pursuing "a very systematic and diligent effort over the past four years that has included extensive input from governments, industry and other stakeholders aimed at many of the same questions raised in this draft, but with virtually none of that reflected in the document."

The draft report also fails to address the "virtual explosion of research, information and real progress in addressing these matters over the past several years," the industry argues. "Any document focused upon the policy challenges in this arena must take these efforts explicitly into account."

An industry source says there is not necessarily a concern that OEHHA may be more aggressive than DTSC on nanotech, but "the potential is certainly there for confusion in an emerging area of great import to California."

The letter is not the first time industry has raised its concerns with the report. In May, representatives of the California Nano Industry Network submitted informal comments to OEHHA and UCSF, indicating that the report blindsided them and also requested that the comment period be dramatically extended so stakeholders could weigh in on the report, sources say. Industry officials, OEHHA and UCSF representatives also recently held a conference call to discuss the report and concerns raised by the report, sources add.

UCSF is reviewing comments on the report, and a revised version is expected in October, an OEHHA spokeswoman says. The revised report is expected to address industry's concerns, the spokeswoman adds.

top of page

California Nano Risk Data Reporting Plan Could Serve As National Model

California's toxics department has unveiled plans to gather risk data on six candidate nanomaterials by requesting manufacturers to submit environmental and other data on various so-called nano metal oxides used in consumer products, a move that could offer a model for other states and EPA on assessing nanomaterials' risks.

The state's plans come as EPA is pushing ahead with efforts to use existing Toxic Substances Control Act (TSCA) authority to issue rules to gather more data on the potential risks of nanomaterials in commerce.

California's Department of Toxic Substances Control (DTSC) may also initiate a second round of data requests for carbon nanotubes, asking manufacturers and others to submit additional information about carbon nanotubes used in various products. The department could also place some of the information gathered in a developing "toxics information clearinghouse" to be used for the state's landmark green chemistry program, officials say.

DTSC and EPA Sept. 22 hosted a public meeting at EPA Region IX's offices in San Francisco to discuss both agencies' efforts on nanotechnology. At the meeting, DTSC officials announced that the second round of its "data call-in" program would entail seeking information from manufacturers regarding nano metal oxides and "quantum dots." The department is using its authority under state pubic health law to request the information.

DTSC's data call-in program involves requesting nanotechnology manufacturers and others to submit environmental or health data. The DTSC's first round of reporting requirements was limited to carbon nanotubes.

For the second round of DTSC's data call-in program, state department officials say they want information on nano silver, nano zero valent iron, nano titanium dioxide, nano zinc oxide, nano cerium oxide and quantum dots. Quantum dots refer to nano-sized semiconductors commonly found in products like solar cells and transistors. The other nano metal oxides are used in a variety of products, including sunscreens.

DTSC says its initial questions for these nanomaterials will focus on analytical test methods for the substances, and their metabolites and breakdown products. DTSC will begin formally requesting this information in the fall.

DTSC may also ask manufacturers additional questions regarding the toxicity of the nanomaterials and other characteristics, DTSC officials said. "In terms of detection in products, one of the areas we could ask is, 'What kind of methodology do you have in detection of the material as it has been incorporated into the product?'" said DTSC Chief Scientist Jeff Wong at the meeting. "So those are important observations."

Wong also reiterated previous comments that through the information requests, DTSC is trying to "put information into the marketplace. We are not trying to start regulating these materials."

Wong added that the nanomaterial data call-in is one of the mechanisms DTSC will use to "populate the green chemistry information infrastructure. As much as we can, we'll place the data into that infrastructure." Wong was referring to a "toxics information clearinghouse" that DTSC and California's Office of Environmental Health Hazard Assessment are currently developing for the California EPA's green chemistry initiative.

Information in the clearinghouse, required under the state's green chemistry law, will be used by DTSC to help identify chemicals of concern to be regulated under upcoming green chemistry rules.

Meanwhile, Jim Alwood of EPA's Office of Pollution Prevention and Toxics told the DTSC/EPA meeting about new and upcoming rules that EPA is developing to collect data on nanomaterials.

Alwood noted that EPA Sept. 17 published its first-time final significant new use rule for single- and multi-walled carbon nanotubes that are used in several applications, including advanced composites, fuel cells and electronics. The rule will ensure that nanomaterials receive appropriate regulatory review, and would require manufacturers and importers to submit a significant new use notice to EPA at least 90 days before commencing that activity, he said.

EPA is also developing a TSCA section 4 rule to require testing for certain nanoscale materials already in commerce, Alwood said. EPA would be particularly interested in classes of nanoscale materials not already being tested by other federal and international organizations, EPA says on its website.

EPA is also developing a rule under Section 8(a) of TSCA regarding information gathering, Alwood said. This rule would also require submission of additional information and require nanomaterial manufacturers to notify EPA of certain data including production volume, methods of manufacture and exposure.

"We spell out exactly what it is we want and go through a public dialogue because I'm guessing not everyone will agree with the information we're asking for," Alwood said. "We're in the pre-proposal stages of this. We're looking for more data, just like DTSC. We all agree we are going to need more."

top of page

In Loss For Industry, EPA Decides To Regulate Perchlorate Under SDWA

EPA has decided to regulate the rocket fuel ingredient perchlorate under the Safe Drinking Water Act (SDWA),  reversing a controversial Bush administration decision not to regulate after finding that setting a drinking water standard would provide a meaningful opportunity to reduce risks posed by the ubiquitous chemical, according to a federal source.

The agency's decision marks a major loss for NASA and chemical and aerospace companies that may face massive cleanup liability as a result of any standard EPA eventually sets, as well as water utilities that may have to treat their drinking water to meet the agency's standard.

But the agency's decision marks a major win for environmentalists and California's Democratic Sens. Barbara Boxer and Dianne Feinstein, who lobbied the agency during the Bush administration to regulate the chemical.

EPA's water office Sept. 29 sent a draft notice to the Office of Management & Budget (OMB) for review outlining its decision to eventually set a maximum contaminant level (MCL) under SDWA. While the agency has decided to eventually set an MCL, the notice sent to OMB does not propose a new standard – an action that occurs separately from the decision to regulate. Sources have long said that setting an MCL will likely result in stricter limits than the agency's current cleanup target of 15 parts per billion (ppb) because EPA is required by law to set the standard at a level strict enough to offset exposures from sources other than drinking water, such as food.

The standard is mandatory for drinking water systems whose water may be contaminated – and acts as an enforceable cleanup standard at waste sites. While the Defense Department (DOD) has not taken an official position on whether EPA should regulate perchlorate, a strict cleanup standard could increase DOD's remediation costs.

Perchlorate -- which is present in drinking water sources in dozens of states -- is one of several substances that inhibits the thyroid's uptake of iodine, a deficiency that can lead to goiter, or swollen neck, and developmental delays and reduced IQ among the children of women who were iodine deficient during pregnancy.

The chemical, which is used in rocket fuel and some fertilizer, among other things, is a ubiquitous environmental contaminant in scores of states, including California, Florida, Texas, New Jersey and Maryland. A recent report from the Government Accountability Office found that the national rate of exposure to perchlorate is generally comparable to levels the office found in 2005.

But faced with uncertainty over how or whether EPA would regulate, several states recently began stepping up their efforts to set or strengthen their drinking water standards for the chemical. New Jersey officials, for example, recently began preparing for a new rulemaking to establish a standard based on a pending final EPA analysis of the science on the chemical's risks. And California's health hazard office is expected to soon issue its response to a petition from environmentalists asking it to strengthen its existing perchlorate drinking water limit of 6 ppb.

Fierce Outcry

The Bush administration decided not to regulate the chemical, prompting a fierce outcry from California lawmakers and environmentalists. The Obama administration decided to revisit the Bush administration's determination, but the agency faced fierce opposition from industry and others.

The agency's Inspector General, for example, earlier this year back calls from industry by recommending that EPA not regulate the chemical under SDWA but instead implement other approaches that would be more effective at reducing risk, such as boosting consumption of iodide that would counteract perchlorate and the other compounds' harmful effects.

The IG said that the agency needs to conduct a cumulative assessment of perchlorate and other compounds that have similar harmful effects on the human thyroid -- an approach the IG suggests EPA should apply to all chemical risk assessments. Using this approach, the IG found that reducing the risk of perchlorate beyond EPA's safe daily exposure limit -- as would likely result from an MCL -- "does not effectively reduce risk."

A coalition of chemical and aeronautics industry groups also recently touted a study indicating that pregnant women's thyroid function is not harmed by drinking water tainted with the rocket fuel ingredient perchlorate in a bid to undermine the findings of a landmark 2006 study that environmentalists have cited to pressure EPA to strictly regulate the chemical.

But the federal source says the agency determined that it will regulate perchlorate under the law. The source says that in making that determination, EPA weighed the law's three criteria -- the potential adverse effects of the contaminant on human health; the frequency and level of contaminant occurrence in public drinking water systems, and whether regulation of the contaminant presents a meaningful opportunity for reducing public health risks.

The federal source says that EPA concluded on the third criteria that setting an MCL will result in a meaningful opportunity to reduce risk. The source says EPA's decision is a "major step" in the debate over the chemical.

An agency spokeswoman says, “EPA is in the process of making a final decision on whether to set a drinking water standard for perchlorate and is in the middle of an inter-agency review process.  Under the previous administration, EPA made a preliminary decision not to regulate perchlorate. Last year, Administrator Jackson directed EPA to re-evaluate the science on perchlorate and to take into consideration the impacts on the most vulnerable populations, infants and young children. As soon the Agency reaches a final decision, we will release it to the public.”

top of page

OMB, Industry Urge EPA To Delay Cancer-Risk Review For Chromium 6

The White House Office of Management and Budget (OMB) and affected industry groups are urging EPA to delay its just issued draft risk assessment of the metal hexavalent chromium (Cr6), which proposes to significantly strengthen the agency's current assessment, until additional research and analysis of the metal's risks are completed.

In comments on a draft version of the assessment, OMB suggests EPA should first assess the risks posed by trivalent chromium (Cr3), a related compound, before finalizing its just-issued draft while industry groups are reiterating calls for the agency to await the results of a pending industry study into the metal's mutagenicity.

Other agencies, however, including the Agency for Toxic Substances and Disease Registry (ATSDR), praise the assessment, calling it “well-written,” and noting that the agency's noncancer oral assessment is similar to ATSDR's. It also describes EPA's assessment of the cancer risk as “scientifically supported and clearly described.”

EPA's new draft assessment for its Integrated Risk Information System (IRIS) database, released Sept. 30, marks the first time that EPA has assessed the cancer risk that Cr6 presents from ingestion.

The agency's last Cr6 assessment, published in 1988, did not include an oral cancer slope factor (CSF), citing a lack of data. “Carcinogenicity by the oral route of exposure cannot be determined,” the 1988 assessment says, but classified the metal as a known human carcinogen if inhaled.

The new draft includes three oral slope factors, or estimates of cancer potency for varying age groups: 8x10^-5 for babies and toddlers under two years of age, 5x10^-5 for children 2 to 16 years and 2x10^-5 for teens and adults older than 16. The agency also considers the assessment of concern to children, and as a result, includes an additional 10x safety factor, known as an age-dependent adjustment factor.

The 1998 assessment included an estimate of Cr6's noncancer oral risks, calculating a reference dose (RfD) of 3x10^-3 milligrams per kilograms of body weight per day (mg/kg-day). The new draft proposes a tighter RfD, or the amount below which the agency considers harm unlikely from consuming on a daily basis over a lifetime, of 9x10^-4 mg/kg-day.

EPA also calculated a reference concentration, or the amount below which the agency considers harm unlikely if inhaled on a daily basis over a lifetime in its 1998 assessment. But the new draft assessment does not include an evaluation of the harmful health effects of Cr6 through inhalation of the metal, saying that analysis will be reconsidered at a later date.

Conservative Linear Approach

One possible reason for the stringency of EPA's risk assessment is that the agency, like California recently did, adopted a conservative linear approach that assumes no safe level of exposure. EPA's 2005 Cancer Guidelines allow the use of a non-linear model -- which assumes a safe threshold level of exposure below which harm will not result -- when the mechanism, or mode of action, of a chemical is known and is not mutagenic. The draft assessment found Cr6 to be mutagenic across all routes of exposure, prompting the linear approach.

Industry groups and other regulated entities fear the agency's assessment could drive stringent new regulatory requirements for the metal, which is used to produce dyes, paints and coatings and also forms when performing “hot work” such as welding and in steel production.

While EPA has previously conducted stand-alone assessments of the risks of Cr6, it has only regulated total chromium in water -- including all of the metal's valence states -- setting a 1992 drinking water cleanup standard of 100 parts per billion (ppb).

But some states, including California and New Jersey, have been moving toward setting stand-alone standards for Cr6. California, for example, in August 2009 produced a draft public health goal for Cr6 in water of 0.06 ppb -- significantly more stringent than its existing 50 ppb standard for total chromium.

One reason for the stricter standard is that total chromium includes Cr3, which is a necessary nutrient in small doses but which environmentalists say masks the harmful effects of Cr6 in total chromium.

In its May 10 comments on an earlier draft version of its assessment, OMB questions whether EPA can update its 1998 risk assessment of Cr6 without also updating its assessment of the risk of Cr3.

Because the current IRIS information for Cr3 does not include a significant discussion or characterize whether or not it is mutagenic, OMB questions, “is EPA now revising its views regarding the carcinogenicity of trivalent chromium? If so, does EPA plan to update its IRIS file for trivalent chromium?” OMB suggests EPA “may want to consider updating the [Cr3] file first as this may then inform the [Cr6] update.”

OMB says in its comments that EPA is “hypothesizing a mutagenic mode of action” based on mice studies that yielded limited results. “EPA has determined that the mutagenic effects of hexavalent chromium are due to its reduction within the cell to trivalent chromium,” OMB says in its comments.

Meanwhile, industry groups and the Defense Department (DOD) are asking EPA to address uncertainties in the assessment regarding the cancer-causing mechanism of the metal, saying EPA's conclusions lacked sufficient evidence to support its conservative methodology. Industry, in particular, is urging EPA to delay its assessment until the completion of a two-year research project intended to determine how the Cr6 causes cancer by ingestion.

The American Chemistry Council (ACC), a chemical industry association, protests that EPA acted “prematurely,” in “choosing not to wait for results of [ACC's] upcoming study,” in a Sept. 30 statement. ACC and the Aerospace Industries Association last year launched a two-year research program intended to determine how Cr6 causes cancer -- in hopes of persuading the agency to use a less stringent, nonlinear modeling approach.

““It is unclear why EPA feels it necessary to act now, rather than wait to review the Cr(VI) studies underway, some of which have already been released for peer review,” according to the statement from Ann Mason, an ACC senior director. “These studies are needed to provide EPA with additional important data and ‘the best available peer-reviewed science’ on any potential effects of Cr(VI) on human health.”

DOD also filed comments in a similar vein, saying in May 5 comments that “it was our understanding that the postulated mechanism underlying chromium-induced genotoxicity and carcinogenicity is still the subject of much research and some scientific debate.”

DOD also indicated that the species of mice used in the bioassays, which found that doses of chromium fed to the rodents caused intestinal tumors, were of a strain that could have confounded the results of the mutagenicity studies. “The mode of action analysis for the tumors used for deriving the cancer potency should be changed, as the data for this strain of mouse cannot support that finding.”

top of page

EPA Plans Rule To Clarify FIFRA Waiver For 'Minimum Risk' Pesticides

EPA is launching a long-awaited rulemaking on its "minimum risk" pesticides exemption, which will establish criteria for pesticides with certain types of safe ingredients that are exempted from federal regulation under the Federal Insecticide, Rodenticide, and Fungicide Act (FIFRA), which controls pesticide sale and use.

Among other things, section 25(b) of FIFRA creates a minimum risk exemption for pesticides containing demonstrably safe active and inert ingredients, such as those containing natural products like dried animal blood, garlic, and white pepper. But the law does not state what constitutes a "minimum risk" pesticide. Both state regulators and industry have long urged EPA to clarify criteria for the exemption, for different reasons. Industry has in the past raised concerns that pesticides that escape FIFRA regulation do not have to prove their efficacy.

Similarly, state regulators have urged EPA to address "minimum risk" pesticides. Though many of these products are regulated under individual state laws, states have argued that the minimum risk exemption contained in FIFRA section 25(b) allows potentially harmful products to slip through federal regulation because of confusion about what products meet the criteria for exclusion. Trying to identify legitimately exempted pesticides poses a significant drain on state regulatory agencies, state representatives have argued.

EPA announced in its action agenda for August its intent to "explore options for clarifying" the current listing of active and inert ingredients that allow products to meet the qualifications for minimum risk pesticides. The agenda says the agency intends to act through both rule and non-rule actions. The agency determined that the current list needs to be made clearer to "facilitate manufacturing processes, enforcement, and consumer choice among products," the action agenda item says. A notice will be published in the Federal Register within the next 12 months, it says.

EPA has long said clarifications to the minimum risk exemption might be necessary and has indicated several times during the past decade it might take up the issue through a rulemaking.

In 2006, for example, an industry group, the Consumer Specialty Products Association (CSPA) filed a petition asking the agency to issue an interim rulemaking to modify the exemption to capture insect repellents claiming to control public health pests, such as mosquitoes, subjecting those manufacturers to registration under FIFRA. CSPA argued at the time that the minimum risk exclusion presented a public health risk if people were using ineffective products to combat public health pests which could be spreading diseases such as West Nile virus.

The CSPA petition met with opposition from small chemical producers, though, who said in 2006 that a move to end the exemption could stymie research efforts into less-toxic alternatives to pesticides, and would put small companies at a disadvantage.

EPA denied CSPA's petition to craft an expedited rule but indicated its intent to seek a possible notice-and-comment rulemaking to clarify the inert and active ingredients list for minimum risk exemptions, saying in a July 18, 2007 letter to CSPA, "There are a number of ways in which the agency might structure revisions to these regulations, and changes to the provision unrelated to your petition might conceivable be proposed. Notice and comment would provide valuable input into the structure of a final rule."

In a more recent example, state regulators urged EPA to consider subjecting 25(b) pesticides to FIFRA regulation, in response to EPA's controversial May draft guidance on false or misleading pesticide product brand names. Several state agencies commented that some products regularly had false or misleading language in their labeling.

"The 25b marketplace is largely unregulated, thereby attracting dubious product labeling practices," the New York State Department of Environmental Conservation said in June 17 comments.

Oklahoma Division of Agricultural Sciences and Natural Resources filed May 24 comments in a similar vein, asking EPA to include minimum risk pesticides within the parameters of the draft guidance, saying that some of these products create more labeling problems than what EPA describes as registered pesticides. "Just because EPA has not taken its lawful duty to register 25(b) products should not exempt those 25(b) products from the same labeling requirements as other pesticides," according to Oklahoma's comments. -- Bridget DiCosmo

top of page

EPA Proposes Tightening Protections For Human Volunteers In Pesticides Tests

EPA has sent for White House review a proposal to strengthen the agency's protections for human subjects taking part in pesticide exposure tests, a rulemaking required under a court settlement with environmentalists seeking strict ethical and scientific standards for such tests.

EPA sent the proposed rule to the White House Office of Management & Budget's Office of Information & Regulatory Affairs (OIRA) on Sept. 29, according to the OIRA website. EPA will be proposing the rule as part of a June settlement with a coalition of environmental and farmworker groups, including the Natural Resources Defense Council (NRDC), EarthJustice and others, in order to resolve a lawsuit the groups filed against the agency to strengthen the testing standards.

The proposed rule language included in the court settlement would close a loophole that allowed some tests to be conducted on pregnant women and children, would eliminate a provision that allowed an "authorized representative" to consent to the testing on behalf of a subject, and would require human testing to adhere to a set of scientific and ethical standards based on recommendations from the National Academy of Sciences (NAS).

In the 2006 lawsuit brought against EPA, the groups argued that the agency's rule setting standards for use of human test data in pesticide decisions -- titled Protections for Subjects in Human Research -- violated language in the fiscal year 2006 appropriations bill that authorized it. Specifically, Congress asked EPA to incorporate the Nuremberg Code on medical experiments and recommendations from the NAS into the rule, as well as a restriction on testing on pregnant women and children, a source said when the settlement was announced.

According to the June settlement, EPA is required to sign a notice of proposed rulemaking within seven months and issue a final rule within 18 months. The coalition will file a motion to stay the case as EPA proposes and implements the rule, and the case will be dismissed if the final rule is consistent with the settlement, an NRDC source said at the time of the settlement.

top of page

Industry Seeks More Time To Comment On EPA Chemicals Reporting Rule

The American Chemistry Council (ACC) is asking EPA to extend by 30 days the public comment period on the agency's proposal to modify a key toxics reporting rule, saying ACC needs more time to address major issues including whether chemical processors should be required to provide processing and use data to EPA under the rule.

In a Sept. 27 letter to EPA, ACC says that some provisions of the proposed rule "go well beyond" the scope of other provisions and will require more time for industry to develop adequate comments than the current Oct. 12 deadline for comment on the proposal. "ACC and its members intend to provide thorough and thoughtful comments on those issues as well, but need more time to develop input on the additional considerations that EPA has raised," the group says.

EPA outlined additional industry reporting requirements in its Aug. 13 proposal to revise its Toxic Substances Control Act (TSCA) Inventory Update Rule (IUR). EPA's proposal would make key changes to the rule and impose new reporting requirements for the next data submission period of June to September 2011.

The proposal hews closely to changes previously announced by EPA, including a longer time period for reporting, more frequent reporting, eliminating upper thresholds for reporting, rejecting more of industry's confidential business information claims, and other changes EPA says will improve chemicals reporting.

The rule is seen by some activists as a "litmus test" for industry on broader TSCA reform. But many in industry have questioned what they see as burdensome new requirements under the proposal. The circuit board manufacturing industry says the proposal would impose first-time burdensome reporting requirements on recycled byproducts and waste, which could affect other industries that recycle byproducts and waste.

ACC wants a comment period extension to comment on issues raised in a provision of the proposal known as Unit V, which includes EPA's request for comment from stakeholders about requiring more processing and use information from downstream users, such as processors. In Unit V, EPA requests stakeholder input on a wide range of IUR-related issues, including whether processors should provide information to EPA under the IUR rule.

"Currently, only manufacturers (including importers) are responsible for providing information required by the IUR rule," even though TSCA section 8(a) allows the agency to collect information from processors.

EPA is seeking comment on three data collection approaches, including "by modification of the IUR rule, via notification issued under a new data reporting mechanism, or using existing subpoena authority. . . . The Agency believes that processors may be more familiar with the processing and use of the chemical substances than manufacturers (including importers), and therefore may be able to provide more complete and accurate exposure-related data."

Other issues raised in Unit V including the timing of the rule's promulgation and the submission period, both of which are slated for 2011. EPA "anticipates promulgating" a final IUR rule by the spring of 2011 and the next scheduled submission period is slated for June 1, 2011 through September 30, 2011. EPA requests comment on the transition to the new IUR rule and says the agency is considering pushing the existing 2011 submission period to later in the year.

EPA also requests comment on how IUR data can be better used to help assess, prioritize and take action on chemicals posing unreasonable risk, particularly to children. "EPA is interested in receiving comments regarding how to use IUR data, including how to amend the rule, to best assist in this effort," the notice says. "Similarly, EPA seeks comment on how to tailor more narrowly the substantive modifications to the IUR contained in this proposal so as to avoid gathering information which EPA or the public would not be able to use."

EPA also asks for comments on the exemptions included in the IUR; plans to collect more exposure-level data as it does in its New Chemicals program; and various thresholds and limits amended in the modifications, among other issues.

Meanwhile, ACC in its recent letter says that it can meet the Oct. 12 deadline for comments on the so-called Unit III of the proposal, which outlines reporting modifications affecting all manufacturers. Unit III includes "more than 80 specific issues or changes that require input," ACC says. "Although the changes outlined in Unit III are substantial and complex, ACC expects to meet the current deadline for comments in this section," ACC says.

top of page