Re: Docket Control Number OEI-100004; Comments on the Addition of Diisononyl Phthalate Category to List of Toxic Chemicals; Proposed Rule (65 Fed. Reg. 53,681)

Dear Sir or Madam:

A. INTRODUCTION AND SUMMARY

The Society of the Plastics Industry, Inc.¹(SPI or Society), on behalf of its Vinyl Formulators Division, is pleased to provide the following comments on the U.S. Environmental Protection Agency's (EPA or Agency) proposal to amend the list of toxic chemicals under the Emergency Planning and Community-Right-to-Know Act (EPCRA) ( 42 U.S.C. § 11001 et seq.) and list diisononyl phthalate (DINP) as a reportable category of chemicals. 65 Fed. Reg. 53,681 (Sept. 5, 2000); 65 Fed. Reg. 69,888 (Nov. 21, 2000). Many SPI members, in particular those in the SPI Vinyl Formulators Division², use DINP in the manufacture of a variety of products. If the rule is finalized as proposed, SPI members and others in industry will be required to evaluate the need for reporting DINP under the Toxic Release Inventory (TRI) provisions of section 313 of EPCRA for DINP. Thus, SPI and its members have a direct and substantial interest in this rulemaking.

DINP is a member of the phthalate esters class of plasticizers, which are used as a manufacturing component in a wide variety of applications, including flooring, wire and cable, wall covering, packaging, and toys. Many SPI members are involved in these application processes and will be directly impacted by the rule as proposed. SPI's principal comments can be summarized as follows:

1. TRI reports are intended to provide the community with information about the release of toxic chemicals. Because DINP releases generally are below detection limits, industry would often report that they have zero releases if the proposal is finalized. The public would not derive any valuable information from these reports, while the reporting burden on industry would be increased.
2. EPA's September 2000 notice is based on a hazard assessment that preliminarily suggests that the chronic health effects criteria of section 313(d)(2)(B) are met. Since three of the premiere studies on DINP appeared between February and October 2000, EPA did not have an opportunity to adequately consider this compelling evidence, which show that the preliminary chronic health effects conclusions were not warranted.
3. The statutory criteria for listing chemicals require that the agency's findings of reasonably anticipated adverse effects be scientifically grounded. The weight of scientific evidence does not support TRI listing of DINP. DINP has been extensively researched, tested and used for more than 50 years without confirmed reports of adverse health effects in children or adults. This is detailed in comments submitted by the Phthalates Esters Panel of the American Chemistry Council, which SPI supports.

For these and other reasons discussed below, the agency should not list DINP as a reportable chemical under EPCRA.

B. COMMENTS

1. The Objectives of EPCRA Are Not Met By Listing DINP

TRI reporting exists for the express purpose of informing the community about toxic chemical releases. In EPA's words, "[t]he basic purpose of this provision [EPCRA § 313] is to make available to the public information about releases of certain toxic chemicals that result from operations of certain facilities in their community."³ This aptly expresses a necessary prerequisite to listing any chemical under EPCRA § 313(d). EPA must determine that the listing serves EPCRA's purpose of informing the public about releases. Congress intended to require annual TRI reporting for chemicals only when there was a reasonable expectation of releases in quantities or circumstances that could cause the anticipated harm.

The monitoring data for DINP in air, drinking water, and surface and ground waters, albeit limited, suggests that little DINP is released as the concentration of DINP is below analytical detection limits.⁴ Thus, providing access to TRI reports that suggest zero releases is of little value to the community. If the EPA's goal is simply to make the community aware that DINP is used in manufacturing processes, that information is available from other reports and is not a basis for listing under EPCRA § 313. To suggest, as EPA will by requiring TRI reports, that DINP presents a risk to human health because it is reasonably anticipated to be released into the environment in proportions that could cause harm would be quite misleading. Such misinformation will not benefit the community and is likely to cause confusion. EPCRA's goals are not met by adding DINP to the list of chemicals subject to TRI reporting.

2. The Scientific Evidence Does Not Support the Listing of DINP as an EPCRA Toxic Chemical

Section 313(d)(2) of EPCRA authorizes EPA to add chemicals to the toxic chemical list if the following criteria are met based on generally accepted scientific principles or laboratory tests:

(A) The chemical is known to cause or can reasonably be anticipated to cause significant adverse acute human health effects at concentration levels that are reasonably likely to exist beyond facility site boundaries as result of continuous, or frequently recurring, releases.

(B) The chemical is known to cause or can reasonably be anticipated to cause in humans

(C) The chemical is known to cause or can reasonably be anticipated to cause a significant adverse effect on the environment because of its toxicity, its toxicity and persistence in the environment, or its toxicity and tendency to bioaccumulate in the environment.

EPA is proposing to list DINP as a toxic chemical based on its hazard assessment that "preliminarily" suggests that DINP meets the chronic health effects criteria of section 313(d)(2)(B) because DINP theoretically caused developmental toxicity, chronic liver and kidney toxicity, and other effects in animal studies.⁵ The weight of scientific evidence, however, does not support the Agency's hazard assessment of DINP or listing DINP under section 313 of EPCRA. In fact, the weight of the evidence strongly supports the conclusion that the effects observed in rodents are highly unlikely to occur in humans. As detailed in the comments filed by the American Chemistry Council, which SPI fully endorses, there is a substantial body of research that provides compelling evidence that tumors in rodents are not relevant for human health assessment.

DINP has been extensively tested to validate its safe use. A number of scientific bodies around the world have studied DINP and none has determined that there is any significant risk to humans associated with typical exposure levels to DINP. DINP has an extensive database that includes test results from toxicity studies that examined possible liver and kidney effects, cancer, reproduction, and development, as well as recent and ongoing research on endocrine modulations. We request that EPA include the premiere studies cited below in its evaluation of DINP. In contrast to EPA's hazard assessment, the following expert reports suggest that DINP does not present carcinogenicity or other chronic human health effects, nor does it present acute human health effects or significant adverse effects on the environment.

• In October 2000, the National Toxicology Program's Center for the Evaluation of Risks to Human Reproduction (CERHR) found that there is minimal concern for the reproductive effects of DINP and low concern about its development effects.⁶ This evaluation resulted from three public Expert Panel meetings and 15 months of deliberation by a 16-member panel of experts consisting of government and non-government scientists.
• In September 2000, the European Union (EU) confirmed that DINP does not require any labeling for cancer, reproductive (fertility), developmental or other related effects based on the scientific evidence. The EU Risk Assessment of DINP is nearing completion and the results of this work should be included in the consideration of EPA's proposal.⁷
• In February 2000, the International Agency for Research into Cancer (IARC) concluded that the mechanism by which extremely high levels of another plasticizer, DEHP, can induce cancer in rodents is not relevant to humans; the same conclusion is appropriate for DINP because of the physicochemical similarities between DINP and DEHP.⁸

Other studies specific to the risk posed by DINP provide further evidence that DINP is not harmful under typical exposure scenarios. Specifically, in December 1998, the Consumer Product Safety Commission expressly stated that "generally, the amount [of DINP] ingested [from toys] does not even come close to a harmful level."⁹

3. Listing DINP May Cause Facilities to Switch to Alternatives That May Not Be As Safe

Our comments support the view that DINP is well-studied, safe as currently used in polymeric products, and is not anticipated to be released in amounts that would trigger significant adverse effects. There is real concern that, if EPA moves forward and lists DINP as a toxic chemical under EPCRA § 313, covered facilities as well as product manufacturers and sellers will seeking to avoid DINP because it would be a "listed" hazardous chemical. Ironically, this may result in switching to alternatives that are not as well studied. Indeed, the Consumer Product Safety Commission specifically asked that toy manufacturers not replace DINP in children's products with chemicals that have not been adequately tested for toxicity. EPA simply should avoid creating a situation that may cause companies to switch from a well-studied low-risk chemical to ones that may cause unintentional harm.

C. CONCLUSION

Because the world's scientific literature does not support the conclusion that DINP presents the statutorily required adverse health effects for listing, and because the underlying goals of EPCRA would not be served by listing, EPA should withdraw its proposal to list DINP as a toxic chemical under section 313 of EPCRA.

SPI thanks the Agency in advance for its consideration of these comments.

Respectfully submitted,

Maureen Healey
Vice President and
Chief Regulatory and State Affairs Officer

Doug Caster
Chair,
Vinyl Formulators Division

Of Counsel:
Peter L. de la Cruz
Keller and Heckman, LLP
Suite 500 West
1001 G Street, N.W.
Washington, D.C. 20001
(202) 434-4141

1. Founded in 1937, The Society of the Plastics Industry, Inc. is the trade association representing the fourth-largest manufacturing industry in the United States. SPI's 2,000 members represent the entire plastics industry supply chain, including processors, machinery and equipment manufacturers and raw material suppliers. The U.S. plastics industry employs 1.3 million workers and provides $274 billion in annual shipments. For more information, see www.plasticsindustry.org.



2. The Vinyl Formulators Division of SPI was formed in 1953 to enhance the growth and prestige of the vinyl formulating industry. The Vinyl Formulators Division continues to pursue this objective through educational programs and the exchange of ideas and experiences. Its goals include compiling and distributing technical, statistical and other data to industry, public and governmental bodies. For more information, see http://www.flexiblevinyl.org.



3. 54 Fed. Reg. 4, 500 (Feb.16, 1988)(emphasis added); see also, 40 C.F.R. § 372.1 (scope and purpose). The information collected is intended to inform the general public and the communities surrounding covered facilities about releases of toxic chemicals.



4. NTP-CERHR Expert Panel Report on Diisononyl Phthalate, Center for the Evaluation of Risks to Human Reproduction at page 22 (Oct. 2000).



5. 65 Fed. Reg. at 53,686.



6. NTP-CERHR Expert Panel Report on Diisononyl Phthalate (Oct. 2000).



7. Publication of the final risk assessment document is expected in June 2001. The August 2000 draft, however, was approved at the Technical Meeting in December after the exposure estimates were revised downward.



8. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Some Industrial Chemicals, Volume 77 (15-22 February 2000).



9. December 2, 1998, U.S. Consumer Products Safety Commission News Release reporting on the results of its study of "The Risk of Chronic Toxicity Associated with Exposure to Diisononyl Phthalate (DINP) in Children's Products." The study also reported that "DINP had little or no effect on reproduction or development."

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