EPA today announced the release of its Problem Formulation and Initial Assessment for 1,4-dioxane, a widely used industrial solvent and ingredient in a variety of products, including cleaners, cosmetics, dyes and paint strippers, which the EPA has classified as “likely to be carcinogenic to humans.” The Problem Formulation and Initial Analysis, part of the agency’s Toxic Substances Control Act (TSCA) Work Plan risk assessment program, concludes that there is no concern for inhalation exposure of ambient air emissions by the general population. However, EPA plans to further assess potential risks to both workers exposed via inhalation during product formulation and use as a cleaning agent and to workers and consumers that use products containing 1,4-dioxane as a contaminant, such as paints, varnishes, adhesives, cleaners and detergents. EPA intends to use existing data and methods to conduct additional risk analysis, review previous health and exposure studies, and “develop margins of exposure and cancer risk estimates.” The Problem Formulation and Initial Assessment also concluded that assessing risk from drinking water exposure is not currently necessary due to ongoing monitoring by EPA’s Office of Water, so “decisions as to whether or not to regulate the contaminant in drinking water will be considered as part of the EPA’s Regulatory Determination process.” In addition, the agency announced that further environmental risk analysis would not be pursued because of the low hazard profile for 1,4-dioxane to aquatic organisms and the lack of hazard data for sediment and soil organisms.
Last week, California’s Department of Toxic Substances Control (DTSC) released its final 2015-17 Priority Product Work Plan outlining the agency’s policy priorities and product categories to be evaluated over the next three years. The Work Plan implements the Safer Consumer Products program, the part of California’s Green Chemistry Initiative that serves to “accelerate the quest for safer products.” In its final form, the Work Plan retains the same seven product categories as were included in the draft Work Plan released in September, although DTSC made changes like adding example products and clarifying or modifying the scope of certain categories.
Selected changes from the draft to final versions of the Work Plan include:
- Beauty, Personal Care, and Hygiene Products – Sunscreen added as an example in this category.
- Building Products – Carpet padding added as an example in this category, and nomenclature-related changes (“engineered wood,” “plywood subfloors,” and “compressed wood flooring products,” are now “Engineered Wood and Laminate Flooring” and “Plywood and OSB Subflooring.” The Work Plan’s list of changes from the Draft Work Plan also includes “insulation” and “wall coverings with flame retardants” as examples included in this category, although they are not actually discussed in the category’s narrative description or table of example products.
- Household, Office Furniture and Furnishings – Curtains added as an example in this category. DTSC also adds that this category constitutes a subset of the Global Product Classification (GPC) standard segment “Household/Office Furniture/Furnishings,” which is divided into three families: “Fabric/Textile Furnishings,” “Household/Office Furniture,” and “Ornamental Furnishings.”
- Cleaning Products – Surface cleaners and wax removers added as examples in this category.
- Clothing – DTSC now states that it “will exclude consideration of protective wear intended exclusively for occupational safety.” In addition, chlorinated paraffins, halogenated compounds, and organophosphates – all flame retardants – were removed from the table of potential candidate chemicals in clothing products.
- Fishing and Angling Equipment – DTSC has clarified the scope of this category, specifying that the agency is “most concerned about fishing weights and gear that might be consumed by water fowl due to characteristics of size, shape and density,” and thus will not consider large weights used in off-shore salmon fishing.
- Office Machinery (Consumable Products) – The product example “Specialty paper” is narrowed down to thermal paper, while “Printer inks” is now ink cartridges.
DTSC stresses that the Work Plan is only “the first step in identifying the next set of Priority Products.” The Work Plan does not identify specific Priority Products or Chemicals of Concern, nor does it establish any new compliance requirements. Rather, the Work Plan is intended to help DTSC “move from these broad [product] categories to specific product-chemical combinations that warrant consideration as potential Priority Products.” Moreover, the Plan is meant to provide “a level of predictability to potential manufacturers, importers, retailers, and other stakeholders.”
According to the Work Plan, the number of Priority Products to be identified in 2015 “will likely be as many as three,” the same number as was announced in 2014. DTSC anticipates ramping up to more than five products in 2016 and 2017.
The Work Plan covers January 2015 through December 2017, and will be updated in 2017 with the next Work Plan, covering 2018 through 2010. However, DTSC could be required to revise this Work Plan before its expiration in the case of two scenarios: if instructed to take action on a particular chemical, product, or product-chemical combination by legislative mandate or executive order; or if the agency grants a petition to add a product-chemical combination to the Priority Products list.
DTSC encourages stakeholders to stay engaged with the Safer Consumer Products program through its “newly enhanced information management system,” CalSAFER. The system facilitates reading or writing comments on proposed regulations, filing petitions, and submitting other documents to DTSC.
On Tuesday, members of the House Energy and Commerce Subcommittee reviewed the draft proposal introduced last week by Rep. John Shimkus (R-IL) to modernize the Toxic Substances Control Act (TSCA). The “TSCA Modernization Act of 2015,” takes a narrower approach to TSCA reform compared to previous proposals, and was crafted with input from members of both parties. The current bill is a “discussion draft,” and Rep. Shimkus announced that he planned to incorporate changes to it before holding a markup on May 14.
Lawmakers and witnesses alike agreed that significant progress had been made in working toward a much-needed update of the nation’s primary chemicals law, which was signed into law in 1976. The Subcommittee heard testimony from officials representing the Alliance of Automobile Manufacturers, American Chemistry Council, and Society of Chemical Manufacturers and Affiliates, and Safer Chemicals, Healthy Families, as well as Jim Jones, the EPA Assistant Administrator for Chemical Safety and Pollution Prevention.
Industry representatives were generally supportive of the bill, particularly its provisions on testing existing chemicals and improving risk management, and concluded that the sections on state preemption and co-enforcement were appropriate. However, because the proposal does not provide a detailed prioritization plan for screening chemicals or specific timelines for risk assessment, the industry witnesses emphasized the need for Congress and the White House to provide EPA with sufficient resources to accelerate the review of existing chemicals and that the bill should be amended to direct TSCA fee revenue to EPA for implementing TSCA, rather than to the general treasury. The chemical trade group representatives also called for various changes to the proposed TSCA Inventory “reset,” so, e.g., manufacturers would not have to submit new Pre-Manufacture Notices for substances that EPA removes from the Inventory and processors would be subject to reporting requirements on use and exposure data.
Assistant Administrator Jones acknowledged that the proposal complies with the Obama Administration’s principles for TSCA reform, but called for clarity on various issues, including the prioritization process and how EPA should consider cost when evaluating risk. Jones emphasized that funding was a major constraint on how many chemicals EPA can review each year, and even assessments requested and paid for by industry could not be completed within the “unrealistically optimistic” six-month timeframe proposed in the discussion draft. Jones expressed concern that by letting industry request unlimited assessments without a prioritization scheme or required minimum for agency-initiated assessments, the review process could be exploited to “delay evaluations for some of the most dangerous chemicals indefinitely.”
Andy Igrejas, director of the Safer Chemicals, Healthy Families coalition of environmental, public health, labor and other organizations, testified on several positive elements he saw in the draft as well as several areas of concern. According to Igrejas, the bill would not “fix the fundamental barrier in current law to EPA imposing risk management on an unsafe chemical,” because EPA would be required to conduct a cost-effectiveness analysis as to whether a chemical’s risk should be mitigated. Igrejas also testified that the legislation should include a “grandfather clause” for state laws that have “become settled matters of public health policy.” Despite these and other problems, Igrejas said the bill could be fixed with small changes to the language.
Last month, the U.S. Environmental Appeals Board (EAB) issued a rare and much-anticipated opinion interpreting the continuing violations doctrine and section 8(e) of the Toxic Substances Control Act (TSCA) in In re Elementis Chromium, TSCA Appeal No. 13-03 (March 13, 2015). The EAB overturned the November 2013 ruling [PDF] by the Administrative Law Judge (ALJ), which found that Elementis Chromium, Inc., a manufacturer of chromium chemicals, had violated TSCA § 8(e) by failing to report to EPA an epidemiological study on hexavalent chromium. In its March 13 decision, the EAB affirmed the ALJ in finding that the “continuing violations” doctrine applies to § 8(e) violations, thus rejecting Elementis’ statute of limitations argument. However, the EAB also held that Elementis had not violated TSCA § 8(e) because the corroborative information reporting exemption applied, and vacated the $2.5 million penalty imposed by the ALJ.
TSCA § 8(e) requires the immediate reporting to EPA of “information which reasonably supports the conclusion” that a substance “presents a substantial risk of injury to health or the environment.” In this case, a trade group of which Elementis was a member commissioned an epidemiological study on exposure to hexavalent chromium and lung cancer. EPA conducted a similar study in 2000, based on data from one facility, while the Elementis study, which finished in 2002, involved multiple “modernized” manufacturing plants. Both studies concluded that there was a positive association between hexavalent chromium exposure and lung cancer. EPA learned of the Elementis study in a 2006 Washington Post article, subpoenaed the study in 2008, and filed an administrative complaint against Elementis in 2010.
The EAB rejected Elementis’ claim that the general five-year federal statute of limitations barred EPA’s enforcement action. Elementis argued that the alleged violation accrued in 2002, when the company obtained the study, so the statute of limitations expired in 2007. However, the EAB found that the continuing violations doctrine, a special rule of accrual meaning that the period of limitations runs anew each day, applies to TSCA § 8(e), meaning that the limitations period only begins to run once the contested information is finally reported. The EAB concluded that the plain language and substance of § 8(e) imposes a continuing obligation, and violations of such are also continuing in nature. In Elementis, the company’s “last act of non-compliance” occurred on November 17, 2008, when the study was submitted to EPA, so the agency’s 2010 administrative complaint was within the five-year period.
Next, the EAB affirmed that the entire study was presumptively reportable as information which reasonably supports the conclusion that a substance presents a substantial risk of injury, rejecting Elementis’ argument that the only reportable information was “the single sentence conclusion regarding an elevated risk of cancer.” Instead, the EAB adopted a broad interpretation of the terms “information” and “reasonably supports,” concluding that Congress intended to address “the underlying data, assumptions, methodology, and analyses that actually provide the verification, corroboration, and substantiation” of the conclusion that a chemical poses a substantial risk of injury.
Nevertheless, the EAB found that the contested study was ultimately exempt from the reporting obligation because EPA established via guidance an exemption for information that is “corroborative of well-established adverse effects.” The EAB diverged from the ALJ’s analysis in finding that the Elementis study addressed a well-established adverse effect, i.e., increased incidence in lung cancer is a well-established adverse effect of exposure to hexavalent chromium. In contrast, the ALJ focused on the dose-response relationship between chromium and cancer, which the EAB characterized as an inapposite description of the potency of the chemical or conclusion about risk.
The EAB further found that the study was “corroborative” of well-established adverse effects, based not on the ordinary meaning of “corroborative,” but on agency guidance documents. This guidance describes that information is non-corroborative when it shows “the effects of a chemical are of ‘a more serious degree or different kind’ than previously perceived.” Therefore, information would be corroborative “if it shows that effects are less severe, they occur only at higher doses, or they occur in a species or strain of test animal, or by a route of exposure, that has been previously documented.” In this case, the study “only revealed statistically significant lung cancer effects at a substantially higher level” than in EPA’s own study. Thus, the Elementis study qualified for the exemption, although the EAB noted that it would have affirmed the ALJ’s decision but for EPA’s self-imposed limitation on “the broad reach of the statute with its interpretation of what information EPA is ‘adequately informed of’ in its guidance documents.”
The Elementis decision raises several interesting issues under TSCA, especially concerning the breadth of information companies must report under § 8(e) and which other TSCA sections might be interpreted as imposing continuing obligations. How EPA reacts to the decision will be instructive, especially if it chooses to refine or redefine its guidance on the corroborative information reporting exemption. Alternatively, Elementis may be of interest to legislators and stakeholders currently involved in negotiating a new framework for TSCA.
The House of Representatives has now joined the Senate in moving toward reforming the Toxic Substances Control Act (TSCA). Yesterday, the House Energy and Commerce Subcommittee on Environment and the Economy announced that it will hold a legislative hearing on a “discussion draft” of the “TSCA Modernization Act” on April 14. The newly unveiled proposal [PDF] comes from Subcommittee Chair Rep. John Shimkus (R-IL), who led last year’s unsuccessful TSCA reform effort in the House. As expected, the draft is significantly narrower in scope than either of the current Senate proposals or Rep. Shimkus’ “Chemicals in Commerce Act,” introduced one year ago.
The draft bill establishes a new system for EPA to evaluate and manage risks for chemicals already on the market, including testing authority, and excises the requirement that EPA take the “least burdensome” regulatory approach to managing risks from harmful chemicals. Instead, when developing a rule to manage a chemical’s risks, the agency would have to consider factors including benefits of the chemical substance, economic consequences, and cost-effectiveness. Under the new system, manufacturers would be able to designate chemicals for risk evaluation, in which case, manufacturers would pay the administrative costs EPA incurs in conducting the evaluation. In addition, the proposal sets timelines for completion of risk evaluations: three years for EPA-selected substances, and 180 days for evaluations initiated by manufacturers. However, there are no provisions for capping the number of evaluations industry can fast-track, or for requiring a minimum number of evaluations to be completed.
The bill would adopt a new safety standard requiring EPA to determine if there is “a reasonable basis for concluding that the combination of hazard from and exposure to the chemical substance under the intended conditions of use has the potential to be high enough to present an unreasonable risk to health or the environment.”
Notably, Rep. Shimkus’ proposal provides a more limited preemption of state laws, overriding them only once EPA has made a final decision on a chemical’s safety. However, there is no grandfather clause exempting California’s Proposition 65, which is included in the legislation from Senators Tom Udall (D-NM) and David Vitter (R-LA).
Rep. Shimkus’ bill authorizes certain state, local, and tribal government officials and healthcare professionals to access Confidential Business Information (CBI), on request, when responding to an environmental release or, in the case of healthcare professionals, to assist in the diagnosis or treatment of patients. It also proposes a system to renew CBI claims after ten years.
In the Subcommittee’s press release, Rep. Frank Pallone, Jr., (D-NJ), Ranking Member of the full committee, called the draft “a good starting point.”
Next week’s hearing will include testimony from EPA Assistant Administrator Jim Jones, of the Office of Chemical Safety and Pollution Prevention. Other panelists have yet to be named.
Since the Senate Environment and Public Works (EPW) Committee’s legislative hearing last week on modernizing the outdated Toxic Substances Control Act (TSCA), critiques, endorsements, and other reactions have continued to roll in from all corners of the TSCA reform universe. Yesterday, Chemical Watch reported that the Alliance of Automotive Manufacturers and the Consumer Electronics Association came out in support of S. 697, the “Frank R. Lautenberg Chemical Safety for the 21st Century Act” introduced by Senators Tom Udall (D-NM) and David Vitter (R-LA). Both industry groups lauded the bipartisan bill for creating a single regulatory scheme that would be consistent across the U.S., which they prefer to the approach put forward in the competing proposal from Senators Barbara Boxer (D-CA) and Edward Markey (D-MA). According to Chemical Watch, the electronics companies Dell and Hewlett-Packard are taking a wait-and-see approach to the proposed bills, while the Retail Industry Leaders Association, whose members include Walmart, Target, and Nike, is still reviewing the legislation with its member companies.
Companies for Safer Chemicals, a coalition coordinated by the American Sustainable Business Council and representing manufacturers including Seventh Generation and Naturepedic, expressed early support for the Boxer-Markey bill, calling S. 697 “insufficient” and faulting its slower timeline for chemical safety assessments. The coalition has also submitted a letter to the EPW Committee suggesting certain improvements to be made to the Udall-Vitter bill, including delayed preemption of state action, loosening Confidential Business Information (CBI) protections to increase transparency through supply chains, a “more robust review schedule,” fully funding TSCA through an uncapped fee system, and making it easier for EPA to restrict articles containing hazardous chemicals.
Earlier this week, Chemical Watch highlighted letters from the California Environmental Protection Agency (CalEPA) [PDF] and several state Attorneys General [PDF], both opposing the Udall-Vitter bill. The state officials object to the legislation’s elimination of co-enforcement and overbroad preemption provision, which they say would prevent state action to regulate dangerous chemicals. CalEPA Secretary Matthew Rodriguez further argued that S. 697 would impede the full implementation of California’s landmark green chemistry law, the Safer Consumer Products program.
Lawmakers and stakeholders are discussing the possibilities for negotiating amendments to the Udall-Vitter bill that could attract additional support from Democrats and the Obama administration.
A related debate has been playing out among legal experts over the Udall-Vitter bill’s safety standard of “unreasonable risk.” A group of former senior EPA legal officials who served in the last four administrations sent a letter to the Senate EPW Committee backing the bill, saying that the “unreasonable risk” standard “as included in S. 697 is not to be interpreted as it has under the existing TSCA.” That letter was in response to a March 16 letter [PDF] from public interest attorneys and environmental law professors, which called the safety standard in S. 697 “deeply problematic.”
Companies that manufacture, import or process nanoscale materials would be subject to reporting requirements under a new proposed rule released today by EPA. EPA is proposing reporting obligations concerning use, exposure, and other factors under section 8(a) of the Toxic Substances Control Act (TSCA). The proposed rule would apply to nanoscale chemical substances in the marketplace that have unique properties related to their size. The agency intends to use this information to determine if any further action under TSCA is needed.
Under the proposed rule [pre-publication version, PDF], companies would be required to report if they manufactured or processed a “discrete form” of a reportable nanoscale substance during the three years preceding the rule’s final effective date. EPA also proposes a continuing reporting requirement for companies intending to manufacture or process a discrete form of a reportable chemical substance after the rule’s final effective date. These manufacturers or processors would be required to report to EPA 135 days before the commencement of manufacturing or processing.
To the extent that it is known or reasonably ascertainable to the reporter, companies would have to submit the following information:
- Specific chemical identity;
- Material characteristics like morphology and surface modifications;
- Physical and chemical properties;
- Maximum weight percentage of impurities and byproducts;
- Production volumes;
- Use information;
- Detailed methods of manufacturing or processing;
- Exposure information, including estimates of numbers of individuals exposed in the workplace or in other scenarios;
- Release information, including estimates of amounts released;
- Risk management practices, such as protective equipment or hazard warnings; and
- Existing data concerning environmental and health effects.
Generally, nanoscale materials are chemical substances that have structures with dimensions “at the nanoscale,” meaning 1-100 nanometers (nm), and may have properties different from the same chemicals with structures at a larger scale, such as greater strength or lighter weight. The proposed rule would apply to substances that are:
- Solid at 25°C and atmospheric pressure; and are
- Manufactured or processed in a form where the primary particles, aggregates, or agglomerates are in the size range of 1-100nm and exhibit unique and novel characteristics or properties because of their size.
The proposed reporting requirements apply to “discrete forms” of reportable chemical substances. In some cases, companies would be required to report separately for multiple nanoscale forms of the same chemical substance. The agency’s intent is to focus on “intentionally manufactured chemical substances at the nanoscale,” so unintended variations in particle sizes between production batches, for example, should not trigger § 8(a) reporting. EPA proposes to distinguish between these “discrete forms” based on a combination of the following three factors:
- a change in process to affect a change in size and/or a change in properties of the chemical substances manufactured at the nanoscale;
- a change in mean particle size of 10% or greater; and
- the measured change in at least one of the following properties, zeta potential, specific surface area, dispersion stability, or surface reactivity, is greater than 7 times the standard deviation of the measured values.
Other examples of discrete forms include nanomaterials with different morphologies (spheres vs. rods) and nanoscale forms of the same material but coated with different substances.
The proposed rule applies to mixtures, including when nanomaterials are manufactured or processed “solely as a component of a mixture, encapsulated material, or composite.” However, if a nanomaterial is incorporated into a mixture, encapsulated material, or composite by the nanomaterial’s manufacturer, the incorporation step does not have to be separately reported.
EPA proposes to apply a modified version of the existing small manufacturer/processor exemption to § 8(a) requirements. Because nanoscale materials are produced at much lower production volumes, EPA seeks to eliminate the 100,000 pound volume threshold for exempted small manufacturers or processors. Instead, a company could qualify as a small manufacturer/processor if it has “sales of less than $4 million” per year.
The proposed rule also excludes certain substances, including nanoclays, DNA, RNA, proteins, and chemical substances “which dissociate completely in water to form ions that are smaller than 1 nanometer.” Certain reporting which would be duplicative is also excepted; e.g., companies that submitted information under EPA’s voluntary Nanoscale Materials Stewardship Program do not need to re-submit, nor do submitters of Premanufacture Notices (PMNs) filed since January 1, 2005.
Information would be collected electronically, using a modified version of the reporting form used by the voluntary NMSP initiative, and compatible with EPA’s existing Central Data Exchange (CDX) and Chemical Information Submission System (CISS), both used for other TSCA reporting. EPA is not proposing an inventory for nanoscale materials, although non-confidential information collected through this proposed rule would be published in ChemView.
In addition to the above proposed reporting requirements, EPA is seeking input on various related issues, including “the possibility of a future rule that would require periodic reporting of chemical substances manufactured at the nanoscale, similar to reporting that occurs under the Chemical Data Reporting (CDR) rule.”
EPA is accepting comments on the proposed rule for 90 days following its publication in the Federal Register. The agency also anticipates holding a public meeting during the comment period.
EPA has made more progress with its Toxic Substances Control Act (TSCA) Work Plan with yesterday’s release of the agency’s final risk assessment for N-Methylpyrrolidone (NMP) or 1-methyl-2-pyrrolidinone, a chemical commonly used in paint and coating removal products. NMP is estimated to be used at over 184 million pounds per year, in paint strippers, agricultural chemicals, electronic cleaning, and petrochemical processing. The risk assessment identifies developmental toxicity risks for pregnant women and women of child-bearing age who have high exposure to NMP, as either consumers or workers. Risks were identified for both acute and chronic exposures, although acute exposure risks could be mitigated by using chemical-resistant gloves and using NMP products for less than four hours a day.
EPA is considering a range of voluntary and regulatory actions to reduce risks from NMP exposure. This is the fifth final risk assessment completed under the TSCA Work Plan.
Today, the Senate Environment and Public Works Committee held a legislative hearing on the “Frank R. Lautenberg Chemical Safety for the 21st Century Act,” the proposal to modernize the Toxic Substances Control Act (TSCA) introduced last week by Senators David Vitter (R-LA) and Tom Udall (D-NM).
Lawmakers heard from Bonnie Englebardt Lautenberg, widow of the late Senator Frank Lautenberg (D-NJ), who said that her husband wanted chemical safety reform to be his “final, enduring legacy,” and warned that opposing the bill would “let the perfect be the enemy of the good.” Other lawmakers and witnesses also emphasized compromise and pragmatism in supporting the legislation. Sen. Vitter called the proposal “the only realistic shot we have at reforming a very broken and dysfunctional system.” Environmental Defense Fund Senior Scientist Richard Denison’s testimony [PDF] characterized Udall-Vitter as “a solid compromise that fixes the biggest problems with our current law” and “the best opportunity ever to reform” TSCA. Sen. Udall called for compromise, approvingly cited today’s New York Times editorial making recommendations for the bill, and suggested that it might be possible to compromise on changes such as co-enforcement, the timing of state preemption, and the minimum number of chemicals to be reviewed.
EPA Assistant Administrator of the Office of Chemical Safety and Pollution Prevention Jim Jones testified that the agency has no position on the Udall-Vitter bill, but that the legislation is consistent with the Obama Administration’s “essential principles” for TSCA reform.
As expected, the issue of state preemption emerged as the main focus of debate during the hearing. In his testimony [PDF], Maryland Attorney General Brian Frosh called the legislation an “evisceration of state authority.” Sen. Cory Booker (D-NJ), who occupies Sen. Lautenberg’s Senate seat, called the bill’s preemption provisions “a serious problem.”
At today’s hearing, Senator Barbara Boxer (D-CA) voiced her opposition to the Udall-Vitter plan, saying in her opening statement that the bill “fails to provide the public health protections needed and is worse than current law,” and noting opposition from over 450 organizations, including Attorneys General from eight states, the Environmental Working Group, Physicians for Social Responsibility, and the United Steelworkers.
Senators Boxer and Edward Markey (D-MA), who introduced a competing plan last week, continued to argue for their proposal’s key points and critique the Udall-Vitter bill. In a press conference yesterday, the Senators said that amending the Udall-Vitter bill to incorporate elements from their proposal would make the legislation acceptable. These elements include nixing state preemption, setting tighter deadlines for EPA action, and directing EPA to regulate asbestos and persistent, bioaccumulative and toxic (PBT) chemicals.
Sen. Boxer also claimed that the proposed legislation was drafted by the American Chemistry Council (ACC), a major industry lobbying group, although Sen. Udall’s staff disputed this, saying that input was taken from the ACC along with other stakeholders, such as the environmental group Natural Resources Defense Council.
Today, EPA and the Food and Drug Administration (FDA) announced a Memorandum of Understanding (MOU) to share data on pesticides and toxic substances. According to a notice published last month in the Federal Register, in response to the FDA’s spring 2014 request, EPA will grant FDA access to information collected under the Toxic Substances Control Act (TSCA) and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), including information claimed by submitters as Confidential Business Information (CBI). This data-sharing initiative “is intended to maximize the utility of data collected under those statutes, and enhance the efficiency of the participants’ regulatory processes and facilitate better risk management activities.” The MOU applies specifically to EPA’s Office of Chemical Safety and Pollution Prevention and FDA’s Foods and Veterinary Medicine Program, Center for Food Safety and Applied Nutrition, and Center for Veterinary Medicine.
FDA and EPA “have complementary roles” regulating substances incorporated into food (including animal feed), animal drugs, and cosmetics. Antimicrobial food wash products, for example, must meet different standards for safety and non-adulteration of food (FDA), and no adverse environmental effects (EPA).
The MOU covers the sharing of non-public information exempt from public disclosure, including CBI and “confidential commercial information” (CCI). Information will be shared “on a reciprocal and as-needed basis” for substances that may be present in human food, animal food and feed, animal drugs, and cosmetics. The MOU provides that each agency will develop internal procedures and designate liaison officers for the information-sharing exchanges and to protect against unauthorized disclosure of CBI or CCI. Appendices to the MOU establish a framework process for information sharing, including specific language to be used in requesting information or responding to a request.
The MOU does not specify any limits as to programmatic uses for shared information. The disclosure of non-public information remains governed by applicable laws and regulations, and non-public information may not be disclosed further or shared with personnel at the other agency that have not been authorized to access non-public information. If EPA requests information from FDA identified as a trade secret, FDA will assess whether the information is in fact trade secret. TSCA/FIFRA-designated CBI requested by FDA will have to be returned to EPA or destroyed when no longer needed. Either agency may choose not to share requested information, or may choose to limit the scope of information provided in response to a request. The agencies may also protect information “in connection with research that has not been peer reviewed.”