EPA Releases First Set of Draft Risk Assessments Under Existing Chemicals Work Plan Effort

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On January 4, EPA  released for public comment draft risk assessments, for particular uses, on five chemicals found in common household products. The draft risk assessments were developed as part of the agency’s Toxic Substances Control Act (TSCA) Work Plan, which identified common chemicals for review over the coming years to assess any impacts on people’s health and the environment. Following public comment, the agency will seek an independent, scientific peer review of the assessments before beginning to finalize them in the fall of 2013.

“The draft risk assessments released today for public review and comment highlight the agency’s ongoing commitment to ensure the safety of chemicals we encounter in our daily lives,” said James J. Jones, acting assistant administrator of EPA’s Office of Chemical Safety and Pollution Prevention. “The public and scientific peer review will ensure use of the best science to evaluate any impacts of these substances on people’s health and the environment.”

The five assessments address the following chemical uses: methylene chloride or dichloromethane (DCM) and n-methylpyrrolidone (NMP) in paint stripper products; trichloroethylene (TCE) as a degreaser and a spray-on protective coating; antimony trioxide (ATO) as a synergist in halogenated flame retardants; and 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8,-hexamethylcyclopenta-[γ]-2-benzopyran (HHCB) as a fragrance ingredient in commercial and consumer products. The draft assessments focus either on human health or ecological hazards for specific uses which are subject to regulation under TSCA. Three of the draft risk assessments— DCM, NMP, and TCE— indicate a potential concern for human health under specific exposure scenarios for particular uses. The preliminary assessments for ATO and HHCB indicate a low concern for ecological health.

EPA recommends the public follow product label directions and take precautions that can reduce exposures, such as using the product outside or in an extremely well ventilated area and wearing protective equipment to reduce exposure. If EPA concludes in finalizing the risk assessments that there is a potential for concern, the agency will take action as appropriate to address possible risks.

The draft assessments were undertaken as part of EPA’s efforts to identify chemicals for review under the TSCA Work Plan, which EPA released in March 2012. At that time, EPA identified 83 chemicals as candidates for review over the coming years and outlined the data sources and other information the agency would use in the reviews. This initiative is part of EPA’s comprehensive approach to enhance the current chemicals management program within the limits of existing TSCA authorities. EPA continues to support updating TSCA to strengthen and modernize the law.

Additional information on the TSCA Work Plan effort and the specific draft risk assessments can be found at: http://www.epa.gov/oppt/existingchemicals/pubs/workplans.html

 

EPA Announces Proposed Revisions to FIFRA Minimum Risk Exemption

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FIFRA:

In a December 31, 2012 Federal Register notice, (77 Fed. Reg. 76,979) EPA announced a new proposed rule that would revise the labeling requirements for minimum risk pesticide products. The proposed rule affects section 25(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) by changing how minimum risk pesticides are identified on product labels as well as the way ingredient lists are organized in the implementing regulations. In addition, producer contact information will be required on product labels.

Under FIFRA’s § 25(b) minimum risk exemption, pesticides with active and inert ingredients which are demonstrably safe do not need to be registered with EPA. These permitted ingredients are listed in 40 CFR 152.25(f), but because of ambiguities across the various ingredient lists, confusion remains as to which ingredients are covered and how they should be labeled, leading to increased regulatory burden and inefficiencies for state regulators. Many chemicals may be known by producers, regulators, and consumers by different names; for example, soybean oil may be described on a product label as “Glycine Soja Oil.”

EPA’s new proposed rule is intended to make clear which active ingredients are permitted in exempted pesticide products, and does not add or remove any ingredients from the list. Instead, EPA will identify permitted active ingredients by re-organizing them in tables including the chemical’s “Label Display Name” (e.g., “Citric Acid”), “Chemical Name” as determined by the Chemical Abstract Services (“CAS”) (e.g., “2-Hydroxypropane-1,2,3-tricarboxylic acid”) and “CAS Registry Number,” a unique identifier which is easy to use for consumers and widely accepted by industry and regulators alike. In addition, the table will include a “Specifications” column which will be empty for most ingredients, but will indicate the United States Pharmacopeia (“USP”) standard for “approximately 20 of the active ingredients.”

Inactive ingredients will also be re-organized into a table similar to the one proposed for active ingredients. This table will codify “List 4A,” the list of chemicals currently maintained on EPA’s website. In addition, EPA proposes to incorporate references to other CFR sections which describe which chemicals may be used as inert ingredients for the purpose of the minimum risk exemption. In the case of pesticides that may come in contact with foods, for which there are no federal tolerance levels or tolerance exemptions, EPA proposes to amend the text of the exemption to direct users to an EPA website for more information on which of the listed chemicals may be used in food-use pesticide products.

Finally, EPA proposes that exempted product labels must use the “label display name” in the product’s ingredient listing. The proposed rule also requires that producers of minimum risk pesticide products must include their company’s contact information (address and telephone number) on the product label. In the case of a product label which includes the name of a company that is not the producer, EPA proposes that the label text should clarify that the product was “packed for,” “distributed by,” or “sold by” the non-producer company.

EPA is requesting comments on various topics related to this proposal, including: the format and information to be included in the new tables; whether reference to an online resource with more information on food-use pesticide tolerance requirements would provide clarity for stakeholders; impacts on state and local agencies; and whether products would need to be reformulated as a result of the changes. The comment period for this proposed rule ends on April 1, 2013.

Verdant Settles EPCRA Enforcement Matter for New Cingular Wireless

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EPCRA:

Verdant is pleased to announce that it helped its client, New Cingular Wireless, reach a favorable settlement with EPA over a longstanding EPCRA enforecement matter involving legacy facilities owned by a predecessor company.  A copy of EPA’s press release is embedded below. 

____________________________________________________________________________________________________

WASHINGTON – The U.S. Environmental Protection Agency (EPA) and New Cingular Wireless (NCW) have reached an administrative settlement requiring the company to pay a civil penalty of $750,000 and spend $625,000 on environmental projects to resolve alleged reporting, planning and permitting violations at 332 legacy AT&T Wireless (AWS) sites now owned by NCW.

The violations, which occurred at AWS sites in 43 states, such as cellular towers, transmitter sites, switching stations and warehouses, included failure to comply with Emergency Planning and Community Right-to-Know Act (EPCRA) reporting requirements related to the presence of sulfuric acid and diesel fuel at sites, inadequate or no Clean Water Act (CWA) Spill Prevention, Control, and Countermeasure (SPCC) Plans, and Clean Air Act (CAA) minor source permitting requirements.

The EPCRA requirements help communities plan for emergencies involving hazardous substances, the CWA’s SPCC rule requires facilities to have oil spill prevention, preparedness, and response plans to help prevent oil discharges to navigable waters and adjoining shorelines, and the minor source permitting requirements under the CAA ensure that air emissions limits are met.

Under the settlement, NCW will provide a certification of EPCRA compliance at 1,356 sites and conduct comprehensive compliance audits of CAA and CWA/SPCC requirements at 1,361 and 41 legacy-AWS facilities, respectively. NCW has also agreed to pay stipulated penalties for all disclosed and corrected violations discovered through these audits.

NCW has also agreed to conduct environmental projects, which will provide hazardous materials awareness and health/safety training to building inspectors and fire fighters. The projects will also support the procurement of emergency response equipment such as fire-fighting equipment, gas meters, hazmat identification equipment, satellite phones and other emergency communications equipment. The seven entities, located in four states that will benefit from the projects are: Palm Beach County Fire Rescue and Georges Lake Volunteer Fire Department, Putnam County, Fla., New York City Fire Department, N.Y., Yancey, Texas Volunteer Fire Department, Texas, and San Diego, County California Office of Emergency Services, Bodega Bay, California Fire Protection District, and Los Angeles, California Police Department Calif.

Since 1998, nearly 6,000 telecommunications facilities have been brought into compliance through more than 30 settlements as part of EPA’s effort to improve compliance in the telecommunications sector.

More information on the New Cingular Wireless settlement: http://www.epa.gov/enforcement/waste/cases/att.html

DTSC Reopens Comment Period on Green Chemistry Regulations

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California Green Chemistry:

On December 20, DTSC delivered everyone an early Christmas present.  The agency announced that it was re-opening the docket to accept public comments on yet another revised version of the Safer Consumer Product Alternative (SCPA) Regulations.  The agency’s announcement is embedded below.  Merry Christmas – better scratch those holiday plans and get back to work!  Surely some are asking themselves “When will this stop and the litigation begin?”

_____________________________________________________________________________________________________

30 DAY PUBLIC NOTICE AND COMMENT PERIOD

NOTICE OF PUBLIC AVAILABILITY OF POST-HEARING CHANGES

SAFER CONSUMER PRODUCT ALTERNATIVES

Department Reference Number: R-2011-02

Office of Administrative Law Notice File Number: Z-2012-0717-04

Pursuant to Government Code section 11347.1, notice is hereby given that the Department of Toxic Substances Control (DTSC) has revised the Initial Statement of Reasons (ISOR) for the Safer Consumer Product Regulations, which establish the criteria for identification and prioritization of chemicals of concern in consumer products, evaluation of their alternatives, and imposition of regulatory responses by adopting chapter 55 to division 4.5 of Title 22, California Code of Regulations, and to amend the Table of Contents. DTSC is revising the ISOR to correct: typographical, spelling, cross-referencing, punctuation and other formatting errors. In addition, DTSC has revised the ISOR to address some substantive drafting issues raised regarding the ISOR. These include, but are not limited to, making more explicit the necessity statement for each provision.

 DTSC mailed the 45-day Public Notice and made it, together with the regulations text and related materials, available for public review and comment on July 27, 2012. A public hearing was held on September 10, 2012, during which DTSC accepted written and oral testimony. In addition, written comments were accepted during the 45-day public comment period, which was extended by 30 days and ended October 11, 2012. DTSC has now made post-hearing changes to the ISOR. DTSC is NOT proposing changes to the regulations text as part of this notice and related public comment period.

 A public comment period for the revised ISOR will commence on December 21, 2012, and close at 5 p.m. on January 22, 2013. Interested persons may submit comments regarding the revised ISOR by e-mail to gcregs@dtsc.ca.gov, by fax to (916) 323-5542, or by mail to:

Ms. Krysia Von Burg

Regulations Coordinator

Department of Toxic Substances Control

P.O. Box 806

Sacramento, CA 95812-0806

 Copies of the revised ISOR are posted to DTSC’s Internet site at: http://www.dtsc.ca.gov/LawsRegsPolicies/Regs/index.cfm and http://www.dtsc.ca.gov/SCPRegulations.cfm and are available for public inspection between 8:00 a.m. and 5:00 p.m. at the Regulations Section located at 1001 I Street, 23rd Floor, Sacramento, California. Requests and inquiries concerning this matter may be directed to Ms. Krysia Von Burg at the address indicated above or by telephone at (916) 324-2810. Additions to the existing text are double-underlined and text deleted from the existing document is shown as strikeout.

 All comments must be received by DTSC by 5:00 P.M. on January 22, 2013, regardless of the form of transmission.

 Technical inquiries regarding the Revised Initial Statement of Reasons should be directed to Ms. Odette Madriago, Chief Deputy Director, at (916) 323-4927. However, it should be noted that oral inquiries are not part of the rulemaking record.   

30 DAY PUBLIC NOTICE AND COMMENT PERIOD 

NOTICE OF PUBLIC AVAILABILITY OF POST-HEARING CHANGES

 

SAFER CONSUMER PRODUCT ALTERNATIVES

 

Department Reference Number: R-2011-02

Office of Administrative Law Notice File Number: Z-2012-0717-04

 

 

Pursuant to Government Code section 11347.1, notice is hereby given that the Department of Toxic Substances Control (DTSC) has revised the Initial Statement of Reasons (ISOR) for the Safer Consumer Product Regulations, which establish the criteria for identification and prioritization of chemicals of concern in consumer products, evaluation of their alternatives, and imposition of regulatory responses by adopting chapter 55 to division 4.5 of Title 22, California Code of Regulations, and to amend the Table of Contents. DTSC is revising the ISOR to correct: typographical, spelling, cross-referencing, punctuation and other formatting errors. In addition, DTSC has revised the ISOR to address some substantive drafting issues raised regarding the ISOR. These include, but are not limited to, making more explicit the necessity statement for each provision.

 

DTSC mailed the 45-day Public Notice and made it, together with the regulations text and related materials, available for public review and comment on July 27, 2012. A public hearing was held on September 10, 2012, during which DTSC accepted written and oral testimony. In addition, written comments were accepted during the 45-day public comment period, which was extended by 30 days and ended October 11, 2012. DTSC has now made post-hearing changes to the ISOR. DTSC is NOT proposing changes to the regulations text as part of this notice and related public comment period.

 

A public comment period for the revised ISOR will commence on December 21, 2012, and close at 5 p.m. on January 22, 2013. Interested persons may submit comments regarding the revised ISOR by e-mail to gcregs@dtsc.ca.gov, by fax to (916) 323-5542, or by mail to:

Ms. Krysia Von Burg

Regulations Coordinator

Department of Toxic Substances Control

P.O. Box 806

Sacramento, CA 95812-0806

 

Copies of the revised ISOR are posted to DTSC’s Internet site at: http://www.dtsc.ca.gov/LawsRegsPolicies/Regs/index.cfm and http://www.dtsc.ca.gov/SCPRegulations.cfm and are available for public inspection between 8:00 a.m. and 5:00 p.m. at the Regulations Section located at 1001 I Street, 23rd Floor, Sacramento, California. Requests and inquiries concerning this matter may be directed to Ms. Krysia Von Burg at the address indicated above or by telephone at (916) 324-2810. Additions to the existing text are double-underlined and text deleted from the existing document is shown as strikeout.

 

All comments must be received by DTSC by 5:00 P.M. on January 22, 2013, regardless of the form of transmission.

 

Technical inquiries regarding the Revised Initial Statement of Reasons should be directed to Ms. Odette Madriago, Chief Deputy Director, at (916) 323-4927. However, it should be noted that oral inquiries are not part of the rulemaking record.  

EPA finalizes withdrawal of TSCA § 8(d) reporting rule for cadmium

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TSCA:

As we previously reported, EPA announced that it would withdraw its TSCA § 8(d) final rule requiring manufacturers of cadmium or cadmium compounds to report certain unpublished health and safety studies. Today, EPA released the pre-publication version of the final rule withdrawing the December 3, 2012 reporting rule. The reporting rule for cadmium was withdrawn due to “significant confusion…in certain industrial sectors subject to the final rule,” including uncertainty about which industries were subject to the rule.

EPA’s action today is based on the agency’s conclusion that the commenters’ concerns constitute good cause to withdraw the reporting rule without prior notice and comment per the Administrative Procedures Act. Likewise, because the withdrawal does not impose any new requirements, EPA found that the action is not subject to any Executive Orders (such as E.O. 12866, “Regulatory Planning and Review”), nor is it subject to the requirements of the Regulatory Flexibility Act or Title II of the Unfunded Mandates Reform Act. Per the Congressional Review Act (“CRA”), EPA will submit the withdrawal document along with other required information to Congress and the Comptroller General. Following section 808 of the CRA, the withdrawal rule will take effect early, on January 2, 2013.   A draft copy of the Federal Register notice is available here:  Prepublication_Cadmium-FRM-Withdrawal_2012-12-20[1].

EPA Withdraws Immediate Final TSCA 8(d) Rule for Cadmium

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TSCA:

On Friday, December 14, Wendy Cleland-Hamnett, Director of the Office of Pollution Prevention and Toxics (OPPT), announced the U.S. Environmental Protection Agency’s (EPA) decision to withdraw the Toxic Substances Control Act (TSCA) section 8(d) immediate final rule published on December 3, 2012.  In its announcment the agency said: “Based on several letters asking questions and raising concerns about the scope and extent of the immediate final rule that indicate that there is significant confusion and uncertainty within certain industrial sectors concerning the rule, EPA has decided to withdraw the immediate final rule.” EPA will announce the withdrawal in the Federal Register, no later than January 2, 2013, the original effective date of the final rule. 

EPA  also said that it “will be considering the questions and concerns raised in response to the immediate final rule and next steps with regard to this rule. EPA will also continue to work with the Consumer Product Safety Commission (CPSC) to reduce exposure to cadmium in consumer products generally, and especially those consumer products used by or around children, such as children’s metal jewelry.”

More information about this development is available at the agency’s website here.  Information about section 8(d) is available here.

DTSC Requests Public Comment on Scientific Peer Review of Green Chemistry Regulations

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California Green Chemistry Regulations:

Yesterday, the Department of Toxic Substances Control (DTSC) notified the public that the agency is adding two external scientific peer review reports to the Safer Consumer Products rulemaking, which was published in the California Regulatory Notice Register (Z-2012-0717-04)on July 27, 2012.  A public comment period for the external scientific peer review reports will commence on November 30, 2012, and close at 5 p.m. on December 30, 2012.

According to the notice, DTSC has complied with Health and Safety Code section 57004 regarding submission of the scientific portions of the proposed safer consumer product regulations to an external scientific peer review. Documents were submitted to scientific peer reviewers through the University of California. Their written reports, which contain an evaluation of the scientific basis of the regulations, have been added to the rulemaking file.  (If truly independent and objective, these comments should make interesting reading, potentially providing ammunition for the legal challenge that seems likely.)

Comments may be submitted by e-mail to gcregs@dtsc.ca.gov, by fax to  (916) 324-1808, or by mail to:

Ms. Krysia Von Burg

Regulations Coordinator

Department of Toxic Substances Control

 P.O. Box 806

 Sacramento, CA 95812-0806

 Tel: (916) 324-2810

 Fax: (916) 324-1808

 The external scientific peer review reports are available at http://www.dtsc.ca.gov/LawsRegsPolicies/Regs/index.cfm or  http://www.dtsc.ca.gov/SCPRegulations.cfm and for public inspection between 8:00 a.m. and 5:00 p.m. at the Regulations Section located at 1001 I Street, 22nd Floor, Sacramento, California. Requests and inquiries concerning this matter may be directed to Ms. Krysia Von Burg at the address indicated above or by telephone at (916) 324-2810. If Ms. Von Burg is unavailable, please call Ms. Jacqueline Arnold at (916) 322-2004.

Inquiries regarding technical aspects of the external scientific peer review report should be directed to Mr. Jeff Wong at (916) 322-2822. If Mr. Wong is unavailable, please call Ms. Odette Madriago at (916) 323-4927. However, such oral inquiries are not part of the rulemaking record.

New EPCRA TRI Website

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EPCRA Toxics Release Inventory (TRI):

On November 19, 2012, EPA rolled out a new website to provide information on how industrial facilities are preventing releases of chemicals. The site shows how industry is making progress in reducing releases reported under Section 313 of the Emergency Planning and Community Right-to-Know Act (ECPCRA).  The site and additional information about the TRI program is available  here. 

FTC Publishes Revised Green Guides

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Green Marketing:

On October 2, 2012, the Federal Trade Commission (FTC) published long-awaited revised guidelines, known as the Green Guides, to aid marketers in properly making environmental benefit claims.   The FTC released its final revisions after a multiyear investigatory process, which included marketing surveys as well as reviewing comments from companies, trade organizations, government entities and individuals.  The the Green Guides lack the force of law, they provide guidance on how to avoid false or misleading environmental marketing claims in violation of Section 5 of the FTC Act, which prohibits unfair or deceptive acts or practices.

Below is a short summary of some of the major changes contained within the final revisions.

Highlights of the Newly Revised Green Guides

General Environmental Benefit Claims: The Green Guides caution against making general environmental benefit claims, such as using the words “green” or “eco-friendly,” without stating the basis for and qualifying these terms. The qualifying information must be clear, prominent and available at the point of sale—so consumers are able to see it before making their purchasing decisions.

Carbon Offsets: Marketers should use competent and reliable scientific evidence and comprehensive accounting methods to support their claims. However, an offset claim is inappropriate if the activity that makes the basis of the claim is required by law. If the offset purchase will pay for an emission reduction that will not occur for at least two years, then marketers are encouraged to disclose this information.

Certifications and Seals of Approval: The Green Guides also make recommendations for certifications and seals of approval used for endorsements. Marketers are encouraged to use environmental certifications or seals that convey the basis for the certification, but if these are not available, then they should clearly identify the product’s specific environmental benefits. Marketers are also encouraged to disclose their material connections with certifying organizations and must verify all express and implied claims when using third-party certification.

Compostable or Degradable:   “Compostable” claims must be based on competent and reliable scientific evidence, showing that product or packaging materials will become usable compost. Marketers should qualify if the product is not able to be composted in a safe or timely fashion. “Degradable” claims do not have to be qualified if the product or package can completely break down within a reasonably short amount of time, typically one year.

“Free-Off”:  “Free-of” claims can be made if the product contains trace amounts, background levels or less of the substance; the substance was not intentionally added to the product; and the amount contained with the product will not cause the type of harm linked to the substance.  The final revision differs from the standard articulated in the draft revision, and it will certainly create challenges for marketers.

 Non-Toxic:  For “non-toxic” claims, marketers should employ competent and reliable scientific evidence showing that the product is safe for people and the environment, unless otherwise qualified.  A product might be considered “non-toxic” under certain agency regulations designed to protect human health, but those regulations might not ensure protection for the environment.

Ozone-Safe:  Marketers are cautioned against misrepresenting that a product is safe for the atmosphere or ozone layer because the FTC finds that these can be unqualified general environmental benefit claims.

Recyclable and Recycled Content: The Green Guides also provide guidance regarding “recyclable” and “recycled content” claims. Recyclable claims should be qualified if recycling facilities are unavailable to 60 percent of consumers or communities to whom manufacturers sell a product. Recycled content refers to material recovered or diverted from waste during manufacturing or post-consumer use. Marketers are advised to qualify claims for products or packaging constructed partly from recycled material and specify the amount of partly recycled material contained therein. In addition, qualified claims should be made for products containing used, reconditioned or remanufactured parts.

Refillable: Marketers should not make unqualified “refillable” claims unless they identify a method to refill the product.

Renewable Materials and Energy : With claims like “made with renewable materials or energy,” the guides provide that marketers should qualify claims with specific information about the renewable materials used, such as what the renewable material is, how it is sourced and what qualifies it as renewable. Also, the Green Guides specify that marketers should qualify claims of renewable energy by specifying the source (e.g., wind or solar). If the power used to manufacture the product or any component of the product comes from fossil fuels, a renewable energy claim is inappropriate unless renewable energy certificates are purchased to link with energy use.

Source Reduction:  Finally, “source reduction” claims should be qualified with the amount of reduction and the basis for comparison from which the claim is made (e.g., “30 percent less runof f than our earlier model”).

 “Sustainable” and “Organic” Are Not Addressed:   The final revisions offer no guidance on claims regarding “sustainability” and whether a product is “organic.” The FTC claims that it lacks a sufficient basis or context to provide guidance on these claims because these terms have numerous meanings among consumers. However, the Green Guides caution marketers from making these types of claims without impunity.

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The complete final revisions to the FTC’s Green Marketing Guides are available here.   Additional information is also available on the FTC’s dedicated website. 

CBO Estimates Senator Lautenberg's TSCA Reform Bill Would Cost $128 Million over the Next Five Years

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TSCA Reform:

On Tuesday, October 2, the Congressional Budget Office published its evaluation of the costs of implementing the amended version of S.847, The Safe Chemicals Act of 2011, which is Senator Lautenberg’s latest attempt to amend the federal Toxic Substances Control Act (TSCA).  Readers will recall that the Senate Committee on Environment & Public Works passed the amended bill on July 25, sending it to the full Senate for a vote.  Our blog post on that version of the bill is available here.

The CBO press release says the following:

“S. 847 would modify the Toxic Substances Control Act (TSCA), the law that regulates the manufacture, importation, and processing of chemicals, with the aim of shifting the burden from the Environmental Protection Agency (EPA) to chemical manufacturers to prove that substances are safe before they enter the marketplace. This new responsibility for chemical manufacturers would be accomplished primarily by increasing the amount of information about chemical toxicity and usage that they would be required to submit to EPA. Enacting this legislation also would require EPA to undertake other activities that would encourage and support the development of safer alternatives to existing hazardous chemical substances.

CBO estimates that implementing this legislation would cost $128 million over the next five years, assuming appropriation of the necessary amounts, as EPA would incur additional administrative costs to meet the new requirements imposed by S. 847.

Enacting S. 847 could affect direct spending and revenues because the bill would increase some existing civil and criminal penalties for violations of TSCA, establish some new civil and criminal penalties for violations related to that act, and authorize EPA to charge fees to chemical manufacturers. Therefore, pay-as-you-go procedures apply to S. 847. CBO estimates that any changes in revenues and direct spending would not be significant.

A copy of the CBO report is available here.