The EPA Inspector General's Report

The task of the Inspectors General of Federal agencies is to examine "all actions of a government agency or military organization. Conducting audits and investigations, either independently or in response to reports of wrongdoing, the OIG ensures that the agency's operations are in compliance with the law and general established policies of the government. Audits conducted by the OIG are intended to ensure the effectiveness of security procedures, or to discover the possibility of misconduct, waste, fraud, theft, or certain types of criminal activity by individuals or groups related to the agency's operation."

At the end of 2011, the Office of the Inspector General (OIG) of the Environmental Protection Agency (EPA) posted Report No. 12-P-0162,"EPA Needs to Manage Nanomaterial Risks More Effectively" to the reports section of its website.

The OIG, in the Introduction to the report, states that the

. . .  purpose of this review was to determine how effectively the U.S. Environmental Protection Agency (EPA) is managing the human health and environmental risks of nanomaterials.

The report notes that

EPA has the statutory authority to regulate nanomaterials. . . . EPA can regulate nanomaterials during their manufacture, formulation, distribution in commerce, use, and/or disposal through the Toxic Substances Control Act (TSCA) . . . nanomaterials in pesticides through the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) . . . . EPA can regulate nanomaterials released into the environment using the Clean Air Act; the Clean Water Act; the Comprehensive Environmental Response, Compensation and Liability Act; or the Resource Conservation and Recovery Act.

However, while EPA is armed with this authority and while EPA has shifted in recent years from depending on nanoindustries to voluntarily supply EPA with information on "production, importation, and use; exposures; risk management practices; hazards; pollution prevention; and physical and chemical properties" to a more active "regulatory approach", "to collect nanomaterials data from manufacturers of industrial chemicals", the OIG, after conducting "this performance evaluation in accordance with generally accepted government auditing standards", "identified a number of shortcomings": At least some of these shortcoming were attributable to the limitations of TSCA:

1) " . . . An absence of toxicity testing and environmental fate data, and a reliance on modeling . . . .Because EPA depends on information reported by industry, it can initially fail to identify chemical risks not self-disclosed by manufacturers."

2) "The program was limited by TSCA's requirement to protect claims of confidential business information (CBI) on industry data submissions. . . . Excessive CBI designations inhibit independent peer reviews, oversight by external parties, and information sharing across EPA offices".

Other short comings are based in structural problems:

1) "EPA doesnot have an agency-wide formal process to disseminate manufacturer data gathered from TSCA and FIFRA data calls." This data is shared between offices only via informal personal relationships (a.k.a "The Grapevine") such as can be found in any office setting. While this form of communication may work to a limited extent, its limits are obvious.

"Because of the growing number of nanomaterial products entering the marketplace and the anticipated receipt of TSCA and FIFRA data following approval of . . . requested information gathering rule changes, it will be increasingly necessary for . . .offices [in EPA] to formally share information anc coordinate their efforts."

Other short comings found by the OIG recall a line from the movie Cool Hand Luke :

Captain, Road Prison 36: What we got here is... failure to communicate.
 

"Through Federal Register notices, program office web pages, public presentations, and meetings EPA has sought to communicate information related to nanomaterials and to gather input from stakeholders. However, the agency as a whole has not provided a transparent overall message about nanomaterials to the general public. . . .The agency should be prepared to communicate to the public any nonconfidential risk information generated or collected through its FIFRA, TSCA, and reseach activities because nanomaterials is emerging issue, it will be important for EPA to keep the public informed on the benefits and risks, how the public might be exposed, and what regulatory approach the agency is taking."

Other short comings are based on the limitations created by (1) a lack of technology designed to detect nanomaterials or remove detected nanomaterials from the ambient atmosphere (" . . .the agency may not be able to monitor, identify, and remediate nanomaterial comtamination if it were to occur in the natural environment") and (2) resource limitations. EPA, like all Federal, State, County and Municipal agencies, constantly face the potential for budget cuts that would severely limit agency programs.

The OIG's report concludes with the recommendation that the EPA's Assistant Administrator for Chemical Safety and Pollution Prevention be tasked with developing "a formal process to assure the effective dissemination and coordination of nanomaterial information across relevant program offices."

While EPA has agreed with this recommendation and has created a "correction plan with milestone dates" to create a formal communications process and structure, other shortcomings, as discussed above, are rooted in the limitations of TSCA, FIFRa and other laws refered to above. Changes in those are outside of EPA's control, as are those caused by the vagaries of budgets and the appropriations process.

Legislation to reform and strengthen TSCA and EPA's regulatory authority have been introduced in both the Senate and the House in both the 111th and 112th Congresses. S.847, the Safe Chemicals Act of 2011, introduced by Senator Frank Lautenberg of New Jersey on April 14, 2011, is the most recent of these bills. Assigned to the Senate Committee on Environment and Public Works Subcommittee on Superfund, Toxics and Environmental Health, hearings on the bill were held on November 17, 2011. No further action on the bill has occured and with elections coming in November of this year, it is unlikely that the bill will be reported out of committee and sent to the Senate floor for debate.

S.847: The Safe Chemicals Act of 2011

Senator Lautenberg:This isn't a reorganization of the way we function here. It is to be another version of TSCA, far less harmful but having a law that does cover the bases.

Introduced by Senator Frank Lautenberg (D-NJ) on 04/14/2011, S. 847, the "Safe Chemicals Act of 2011", is the third bill introduced in the last two years with the intent of reforming and strengthening the Toxic Substances Cotrol Act . S. 3209, the "Safe Chemicals Act of 2010", also introduced by Senator Lautenberg, and H.R. 5820, the "Toxic Chemicals Safety Act of 2010", introduced by Representives Bobby L. Rush (D-IL-1st) and Henry Waxman (D-CA-30th), were intoduced during the 2nd Session of the 111th Congress, but died in committee when the 111th Congress adjourned sine die.

As was noted by a witness at a hearing of the Senate Environment and Publicworks Superfund, Toxics and Environmental Health Subcommittee on 02/04/2011

. . . while TSCA was an important step when it was first passed in 1976, it is the only major environmental statute that has not been reauthorized since its initial passage. TSCA is clearly showing its age and its limitations.

A recent article in Pediatrics discusses the limitations of TSCA in greater detail than is possible in this posting.

S. 847 would amend TSCA in several ways.

1- Manufacturers and processors would be required to

submit the minimum data set for the chemical substance to the Administrator--

 

        `(A) for new chemical substances, concurrent with the notice required under section (5)(a)(1)(A); and

 

        `(B) for existing chemical substances, on the earlier of--

 

          `(i) 18 months after the date on which the chemical substance is assigned to a priority class under section 6(a); and

 

          `(ii) 5 years after the date of enactment of the Safe Chemicals Act of 2011.

         

 

2- Manufacturers and processors would have restrictions placed on them regarding both new chemicals and new uses of existing chemicals:

SEC. 6. MANUFACTURING AND PROCESSING NOTICES.

 

    Section 5 of the Toxic Substances Control Act (15 U.S.C. 2604) is amended to read as follows:

 

`SEC. 5. MANUFACTURING AND PROCESSING NOTICES.

 

    `(a) New Chemical Substances and New Uses of Chemical Substances-

 

      `(1) NEW CHEMICAL SUBSTANCES- Except as provided in subsection (d), no person may manufacture or process a new chemical substance unless--

 

        `(A) the person submits to the Administrator a notice, in accordance with subsection (c), of the intention of the person to manufacture or process the substance;

 

        `(B) the person complies with subsection (b); and

 

        `(C) the Administrator finds that--

 

          `(i) the manufacturers and processors have established that the chemical substance meets the safety standard under section 6(b); or

 

          `(ii) the new chemical substance, or a metabolite or degradation product of the chemical substance, as applicable, is not, and is not expected to be--

 

            `(I)(aa) manufactured in a volume of more than 1,000,000 pounds annually; or

 

            `(bb) released into the environment in a volume of more than 100,000 pounds annually;

 

            `(II) a known, probable, or suspected reproductive, developmental, neurological, or immunological toxicant, carcinogen, mutagen, or endocrine disruptor;

 

            `(III) persistent and bioaccumulative;

 

            `(IV) found in human cord blood, or otherwise found in human blood, fluids, or tissue, unless the chemical substance, metabolite, or degradation product is naturally present at the level commonly found in that medium; or

 

            `(V) found in food, drinking water, ambient or indoor air, residential soil, or house dust, unless the chemical substance, metabolite, or degradation product is naturally present at the level commonly found in that medium.

 

      `(2) NEW USES OF EXISTING CHEMICAL SUBSTANCES PRIOR TO SAFETY STANDARD DETERMINATION-

 

        `(A) IN GENERAL- Except as provided in subparagraph (B), with respect to an existing chemical substance for which the Administrator has not made a safety standard determination under section 6, no person may manufacture or process the chemical substance--

 

          `(i) for a use that was not ongoing on the date of enactment of the Safe Chemicals Act of 2011; or

 

          `(ii) at a volume that is significantly increased from the volume as of the date of enactment of the Safe Chemicals Act of 2011.

 

        `(B) EXCEPTION- A person may manufacture or process a chemical substance in a manner prohibited by subparagraph (A), if the person--

 

          `(i) submits to the Administrator a new or updated declaration under section 8(a); and

 

          `(ii) complies with subsection (b).

 

      `(3) NEW USES OF EXISTING CHEMICAL SUBSTANCES THAT MEET THE SAFETY STANDARD-

 

        `(A) IN GENERAL- For an existing chemical substance for which the Administrator has determined under section 6(b) that the manufacturers and processors of the chemical substance have established that the substance meets the applicable safety standard, no person may manufacture or process the chemical substance for uses, at production volumes, or in manners other than those the Administrator specified in the safety standard determination, unless--

 

          `(i) the manufacturer or processor submits to the Administrator--

 

            `(I) a notice of the intention of the manufacturer or processor to manufacture or process the substance for a new use, at a new production volume, or in such other manner as is inconsistent with a specified condition or term for that substance; and

 

            `(II) all updates to the minimum data set relevant to the new use, new production volume, or other new manner of manufacturing or processing;

 

          `(ii) the notice under clause (i)(I) indicates that the chemical substance will continue to meet the safety standard if the allowed uses, production volumes, or other specified conditions or terms for that chemical substance are revised to encompass the new use, production volume, or other manner of manufacturing or processing; and

 

          `(iii) the Administrator determines that the manufacturer or processor submitting the notice has established that the chemical substance will continue to meet the safety standard if the allowed uses, production volumes, or other specified conditions or terms for that substance, are revised to encompass the new use, production volume, or other manner of manufacturing or processing.

         

3- Priority classes of chemical substances would be established:

      `(2) CHEMICAL SUBSTANCES REQUIRING IMMEDIATE RISK MANAGEMENT (PRIORITY CLASS 1)-

 

        `(A) DEFINITION OF PRIORITY CLASS 1- In this section, the term `priority class 1' means a priority class that contains chemical substances that the Administrator determines require immediate risk management.

 

        `(B) ASSIGNMENT TO PRIORITY CLASS 1- The Administrator shall assign a chemical substance to priority class 1 if the Administrator determines that the chemical substance is, or is degraded and metabolized into, a persistent, bioaccumulative, and toxic substance with the potential for widespread exposure to humans or other organisms.

 

        `(C) INITIAL ASSIGNMENT- Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2011, the Administrator shall assign not less than 20, but not more than 30, chemical substances to the initial priority class 1.

       

    . . . (i) EXPEDITED EXPOSURE REDUCTION- As soon as practicable, but not later than 18 months after the date on which a chemical substance is assigned to priority class 1 under this paragraph, the Administrator shall impose conditions in accordance with subsection (c) on the manufacturing, processing, use, distribution in commerce, and disposal of a chemical substance assigned to priority class 1 that the Administrator determines necessary to achieve the greatest practicable reductions in human or environmental exposure to the chemical substance.

      `(3) CHEMICAL SUBSTANCES REQUIRING SAFETY STANDARD DETERMINATIONS (PRIORITY CLASS 2)-

 

        `(A) DEFINITION OF PRIORITY CLASS 2- In this section, the term `priority class 2' means a priority class that contains chemical substances that Administrator determines require safety standard determinations.

 

        `(B) ASSIGNMENT TO PRIORITY CLASS 2-

 

          `(i) IN GENERAL- Subject to clause (ii), if the Administrator determines, based on any more-than-theoretical concern, that there is uncertainty as to whether a chemical substance would satisfy the safety standard in a determination made under subsection (b), the Administrator shall assign that chemical substance priority class 2.

    `(4) CHEMICAL SUBSTANCES REQUIRING NO IMMEDIATE ACTION (PRIORITY CLASS 3)-

       

        `(A) DEFINITION OF PRIORITY CLASS 3- In this section, the term `priority class 3' means a priority class that contains chemical substances that the Administrator determines require no immediate action.

           

            `(B) ASSIGNMENT TO PRIORITY CLASS 3- The Administrator shall assign a chemical substance to priority class 3 if the chemical substance has intrinsic properties such that the chemical substance, as determined by the Administrator, does not and would not, at any stage of the lifecycle of the chemical substance, pose any risk of adverse effects to human health or the environment under existing, proposed, or anticipated levels of exposure to, or production or patterns of use of, that chemical substance.

            4- The burden of proving the safety of chemicals would shift from the EPA to manufacturers and processors:

              `(b) Safety Standard Determinations for Chemical Substances-

             

                `(1) IN GENERAL-

             

                  `(A) APPLICATION- This paragraph applies to the determination, or redetermination, of whether a chemical substance meets the applicable safety standard of this title.

             

                  `(B) BURDEN OF PROOF-

             

                    `(i) IN GENERAL- Under this title, the manufacturers and processors of a chemical substance, at all times, bear the burden of proving that the chemical substance meets the applicable safety standard.

             

                    `(ii) DUTIES- Under this title, it shall be the duty of--

             

                      `(I) the manufacturers and processors of a chemical substance to provide sufficient information for the Administrator to determine whether the chemical substance meets the applicable safety standard; and

             

                      `(II) the Administrator to determine whether the chemical substance meets the applicable safety standard.

                `(2) DUTIES-

             

                  `(A) MANUFACTURER AND PROCESSOR DUTIES-

             

                    `(i) INITIAL SAFETY STANDARD DETERMINATION SUBMISSION-

             

                      `(I) IN GENERAL- By the date that is 30 months after the date on which a chemical substance is assigned to priority class 2 under subsection (a), the manufacturers and processors of a chemical substance shall--

            `(aa) update the minimum dataset, if the data set was submitted prior to the assignment of the chemical substance to priority class 2 under subsection (a);

            `(bb) submit to the Administrator any additional information the Administrator may require to make a safety standard determination, including any information the Administrator determines is necessary to be developed by testing; and

            `(cc) indicate whether the chemical substance, including specified uses to be evaluated and any proposed conditions on the specified uses, meets the safety standard.

            5- The Administrator of the EPA would be empowered, if a determination is made that a chemical poses a risk to the environmental and/or the public to

            . . .  impose conditions on the manufacture, processing, use, distribution in commerce, or disposal of a chemical substance, or mixture or article containing that chemical substance, in accordance with subsection (b)(2)(B)(ii)(II), including--

             

                `(1) a requirement limiting the quantity of the substance that may be manufactured, processed, or distributed in commerce;

             

                `(2) a requirement--

             

                  `(A) prohibiting the manufacture, processing, or distribution in commerce of the substance for a particular use in a concentration in excess of a level specified by the Administrator in conditions under subsection (b)(2)(B)(ii)(II); or

             

                  `(B) limiting the quantity of the substance that may be manufactured, processed, or distributed in commerce for--

             

                    `(i) a particular use; or

             

                    `(ii) a particular use in a concentration in excess of a level specified by the Administrator in conditions established under subsection (b)(2)(B)(ii)(II);

             

                `(3) a requirement that the substance be marked with or accompanied by clear and adequate warnings and instructions with respect to use, distribution in commerce, or disposal, or any combination of such activities, with the form and content of the warnings and instructions prescribed by the Administrator;

             

                `(4) a requirement that manufacturers and processors of the substance--

             

                  `(A) make and retain records of the processes used to manufacture or process the substance; and

             

                  `(B) monitor or conduct tests that are reasonable and necessary to ensure compliance with this Act;

            6- In submitting required information to the EPA, "trade secrets" would still be protected, but information that a manufacturer or processor designated as "confidential business information" would need to have an explanation and justification submiited with it, explaining why the information should be considered as confidential.

            7- Decisions and orders of the EPA regarding chemical substances, as well as data submitted by manufacturers and processors would be posted to the EPA's website, in an effort to make it more readily available to communities that could be affected by exposure to chemical substances.

            8 - States and municipalities would still have the right to enact or adopt regulations affecting chemical manufacturers:

            `SEC. 18. PREEMPTION.

             

              `Nothing in this Act affects the right of a State or a political subdivision of a State to adopt or enforce any regulation, requirement, or standard of performance that is different from, or in addition to, a regulation, requirement, liability, or standard of performance established pursuant to this Act unless compliance with both this Act and the State or political subdivision of a State regulation, requirement, or standard of performance is impossible, in which case the applicable provisions of this Act shall control.'.

            The Environmental Defense Fund has created a chart summarizing how the 2011 act differs from the 2010 act, as well as one summarizing how S. 847 would strengthen TSCA.

            Some of S. 847's language appears to be applicable to the nanotech community:

              `(C) INCLUSIONS- Notwithstanding molecular identity, the Administrator may determine that a variant of a chemical substance is a new chemical substance under section 5(a)(6).';

                `(20) SPECIAL SUBSTANCE CHARACTERISTIC-

             

                  `(A) IN GENERAL- The term `special substance characteristic' means a physical, chemical, or biological characteristic, other than molecular identity, that the Administrator determines, by order or rule, may significantly affect the risks posed by substances exhibiting that characteristic.

             

                  `(B) CONSIDERATIONS- In determining the existence of special substance characteristics, the Administrator may consider--

             

                    `(i) size or size distribution;

             

                    `(ii) shape and surface structure;

             

                    `(iii) reactivity; and

             

                    `(iv) any other properties that may significantly affect the risks posed.';

                `(6) CHEMICAL SUBSTANCES EXHIBITING SPECIAL SUBSTANCE CHARACTERISTICS-

             

                  `(A) DETERMINATION- The Administrator shall determine by order or rule that a variant of a chemical substance exhibiting 1 or more special substance characteristics--

             

                    `(i) is a use that is separate from any use of the chemical substance that does not exhibit the special substance characteristics; or

             

                    `(ii) is a new chemical substance.

             

                  `(B) REQUIREMENTS FOR VARIANTS THAT ARE SEPARATE USES- In the case of a chemical substance that the Administrator determines to be a separate use based on the special substance characteristics of the chemical substance, the manufacturer or processor shall satisfy such further conditions as the Administrator establishes, by order or rule.

             

            While efforts to reform and strengthen TSCA has received support from representives of various large chemical companies, among them Dow Chemical, DuPont, and BASF, chances for the passage of S. 847 should be considered slim at best. S. 847 has been introduced at a time when an anti-regulatory ideology is being openly expressed in the House and Senate, as is evident remarks made by Senator David Vitter (R-LA) during the 02/04/2011 hearing:

            . . . . Two, I think a European registration, evaluation and authorization of chemical substances -- a REACH-style program would threaten to kill innovation in the U.S. and is a real recipe for hamstringing small and medium-size manufacturers in particular.

            . .  . Five, I think the peer review process needs to ensure that the peers are absolutely independent. And this means that cherry-picking of research by activists in federal agencies needs to end as well.

            And six, if EPA is going to decide to utilize resources to re- review a chemical prior to the otherwise established scheduled review period, as it has recently, that needs to be -- again, to come back to my central theme -- based on sound science, not simply a New York Times article that, quite frankly, uses politicized science.

            A note of thanks to Bloomberg Government for supplying a copy of the transcript from the 02/04/2011 hearing.