65 FR 67 pgs. 18097-18101 - TSCA Section 21 Petition; Response to Citizens' Petition
Type: NOTICEVolume: 65Number: 67Pages: 18097 - 18101
Docket number: [OPPTS-211044A; FRL-6496-6]
FR document: [FR Doc. 00-8543 Filed 4-5-00; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
ENVIRONMENTAL PROTECTION AGENCY
[OPPTS-211044A; FRL-6496-6]
TSCA Section 21 Petition; Response to Citizens' Petition
AGENCY:
Environmental Protection Agency (EPA).
ACTION:
Notice.
SUMMARY:
On December 27, 1999, EPA received a petition under section 21 ofthe Toxic Substances Control Act (TSCA) from People for the Ethical Treatment of Animals(PETA) on its own behalf and on behalf of four other organizations. The petition requests thatEPA initiate TSCA rulemaking proceedings with respect to all chemicals included on the HPV(High Production Volume chemical) Challenge Program list as updated through the date ofinitiation of the requested proceedings. Specifically, the petition requests that EPA issue a TSCAsection 8(a) Preliminary Assessment Information Reporting (PAIR) rule and a Health and SafetyData Reporting rule under TSCA section 8(d). For the reasons set forth in this notice, EPA has denied the petition to initiate rulemaking.
FOR FURTHER INFORMATION CONTACT:
For general informationcontact: Barbara Cunningham, Director, Office of Program Management and Evaluation, Office of Pollution Prevention and Toxics (7401), Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 554-1404; e-mail address: TSCA-Hotline@epa.gov.
For technical information contact: Frank D. Kover, Chemical ControlDivision (7405), Office of Pollution Prevention and Toxics, Environmental ProtectionAgency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephonenumber: (202) 260-8130; e-mail address: ccd.citb@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general. This action may, however, be ofparticular interest to U.S. chemical manufacturers (defined by statute to include importers) andprocessors. Because other entities may also be interested, the Agency has not attempted todescribe all the specific entities that may be affected by this action. If you have any questionsregarding the applicability of this action to a particular entity, consult the technical person listedunder "FOR FURTHER INFORMATION CONTACT."
B. How Can I Get Additional Information, Including Copies of this Document or OtherRelated Documents?
1. Electronically . You may obtain electronic copies of this document, andcertain other related documents that might be available electronically, from the EPA InternetHome Page at http://www.epa.gov/. To access this document, on the Home Page select "Lawsand Regulations" and then look up the entry for this document under " FederalRegister -Environmental Documents." You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/. A copy of the petition and itssupplement are available on EPA's homepage at http://www.epa.gov/chemrtk/sc21main.htm.
2. In person . The Agency has established an official record for this actionunder docket control number OPPTS-211044A. The official record consists of thedocuments specifically referenced in this action, any public comments received during anapplicable comment period, and other information related to this action, including anyinformation claimed as Confidential Business Information (CBI). This official record includes thedocuments that are physically located in the docket, as well as the documents that are referencedin those documents. The public version of the official record does not include any informationclaimed as CBI. The public version of the official record, which includes printed, paper versionsof any electronic comments submitted during an applicable comment period, is available forinspection in the TSCA Nonconfidential Information Center, North East Mall Rm. B-607,Waterside Mall, 401 M St., SW., Washington, DC. The Center is open from noon to 4 p.m.,Monday through Friday, excluding legal holidays. The telephone number for the Center is (202) 260-7099.
II. Background
A. What is a TSCA Section 21 Petition?
Section 21 of TSCA allows citizens to petition EPA to initiate a proceeding for theissuance, amendment, or repeal of a rule under TSCA sections 4, 6, or 8 or an order under TSCAsections 5(e) or 6(b)(2). A section 21 petition must set forth facts which the petitioner believesestablish the need for the action requested. EPA is required to grant or deny the petition within90 days of its receipt. If EPA grants the petition, the Agency must promptly commence anappropriate proceeding. If EPA denies the petition, the Agency must publish its reasons for thedenial in the Federal Register . Within 60 days of denial or no action, petitioners maycommence a civil action in a U.S. District Court to compel initiation of the requestedrulemaking. When reviewing a petition for a new rule, as in this case, the court must provide anopportunity for de novo review of the petition. Pursuant to TSCA section21(b)(4)(B)(ii), "if the petitioner demonstrates to the satisfaction of the court by a preponderanceof evidence that ... there is a reasonable basis to conclude that the issuance of such [TSCAsection 8 rules] is necessary to protect health or the environment against an unreasonable risk ofinjury to health or the environment" the court can order EPA to initiate the requested action.
B. What Action is Requested Under This TSCA Section 21 Petition?
On December 27, 1999, EPA received a TSCA section 21 petition from PETA on its own behalf and on behalf of the PhysiciansCommittee for Responsible Medicine (PCRM), the Doris Day Animal League (DDAL), theInternational Marine Mammal Project of Earth Island Institute, and the National Anti-VivisectionSociety (NAVS). The petitioners supplemented their original petition with additional referencesin a letter, dated January 19, 2000. The petition and its supplement are in the docket and are also available athttp://www.epa.gov/chemrtk/sc21main.htm.
The petition asks EPA to initiate rulemaking proceedings with respect to allchemicals included in the HPV Challenge Program as updated through the date of initiation ofthe requested proceedings for the issuance of :
1. A TSCA section 8(a) PAIR rule (40 CFR part 712).
2. A Health and Safety Data Reporting rule under TSCA section 8(d) (40 CFR part 716).
The petitioners further petition that "[s]uch rule[s] should neither be limited toparticipants in the Challenge Program nor exclude substances or mixtures as to which aparticipant has enrolled in the Program." While the petitioners recognize that companies are obligated under TSCA section 8(e) to report to the Agency information suggesting that a chemical poses a substantial risk to health or the environment, they are asking the Agency to initiate the requested rulemakings in order to obtain essentially exculpatory information from companies that might "exonerate" a chemical so that additional testing would not be needed.
This request is based in part upon assertions that regulations requiring thesubmission of existing hazard test data provide a better approach for implementing the HPVChallenge Program and associated TSCA section 4 HPV test rule(s) than the approach currentlyutilized, namely, the voluntary submission of relevant existing screening-level hazard test data inconnection with sponsorship of chemicals under the HPV Challenge Program or as comments onproposed HPV rule(s) under TSCA section 4. The HPV Challenge Program and associated testrule(s) are part of a broader Agency program called the "Chemical Right-to-Know Initiative." See http://www.epa.gov/chemrtk/ for a description of the Chemical Right-to-Know Initiative, including the HPV Challenge Program).
III. Disposition of Petition
EPA agrees with the underlying general premise of the petition, i.e., that relevant extant hazard data on the HPV Challenge Program chemicals, both "positive" data that indicate an effect and "negative" data that do not indicate an effect, should be considered by the Agency and made publicly available before any screening-level hazard testing (animal or non-animal) under the HPV Challenge Program or associated test rule(s) is conducted. However, EPA does not believe that it is required to grant the petition under the relevant standard set forth in TSCA section 21(b)(4)(B)(ii), namely that "there is a reasonable basis to conclude that the issuance of such a rule or order is necessary to protect health or the environment against an unreasonable risk of injury to health or the environment." The petition does not argue that the requested rules arenecessary to protect against an unreasonable risk to health or the environment, but rather asserts that the TSCA sections 8(a) PAIRand 8(d) rules provide a more efficient and effective approach to obtaining existingscreening-level hazard data on HPV Challenge Program chemicals. Regardless of the validity ofthis assertion, it would not compel the Agency to take the requested action under TSCA section 21.
Moreover, as a policy matter, EPA does not believe that the petitioner's approach ismore efficient and effective than the approach already being pursued by the Agency under theHPV Challenge Program and associated test rule(s). It should be recognized that the presence of achemical on the HPV Challenge Chemical List is based upon production and/orimportation volume for chemicals reported under the 1990 Inventory Update Rule (IUR), see 40 CFR part 710 for the current IUR regulations, and does not imply that any additional testing orre-testing is needed. Following the guidance provided by EPA, a comprehensive search for and review of existing toxicity studies is occurring and will occur for each of the chemicals in the HPV Challenge Program and any other chemicals listed under associated HPV test rules (see EPA guidance documents on searching for chemical information and assessing adequacy of existing data at http://www.epa.gov/chemrtk/guidocs.htm). The collection of these data is already a fundamental part of both the HPV Challenge Program and associated test rule(s). EPA firmly believes that all stakeholders in the HPV Challenge Program share the goal of avoiding unnecessary testing, in particular the participants who are and will be gathering and making publicly available extant test data and only developing data where screening level data are needed. Further, considering the significant costs and resource burdens involved in animal testing EPA perceives no motivation on the part of program participants or others for re-testing where adequate data already exist.
Finally, EPA disagrees with petitioners' opinion that rules under TSCA sections 8(a)PAIR and 8(d) are necessary to fulfill the objectives of the HPV Challenge Program. The Agencybases its position on this matter on the following considerations:
A. The HPV Challenge Program Maximizes the Use of Existing Data
Theconcerns expressed by the petitioners regarding animal testing have been and continue to berecognized and carefully considered by EPA. Recognition of those concerns is reflected in theAgency's letter of October 14, 1999 (see http://www.epa.gov/chemrtk/ceoltr2.htm) to HPV ChallengeProgram participants. Specifically, the October 14 letter clearly already addresses the petitioners'concerns for maximizing the use of existing data. The second listed principle in the October 14letter states that "Participants shall maximize the use of existing and scientifically adequate datato minimize further testing." The letter also indicates that EPA is firmly committed to reducing and eliminating the use of animals during any HPV chemical testing that must be conducted. EPA works domestically within the framework of the Interagency Coordinating Committee for the Validation of Alternative Methods (ICCVAM) and internationally with the Organization for Economic Cooperation and Development (OECD) to ensure the scientific acceptability of alternative test methods for regulatory as well as international data sharing purposes.
The tenth principle listed in the October 14 letter states that"Companies shall allow 120 days between the posting of test plans and the implementation oftesting plans." Anyone (including companies not participating in the HPV Challenge Program aswell as any other person) having relevant test data is encouraged to submit them during the120-day review period following posting of test plans and "robust" (i.e., detailed) summaries ofscientifically adequate extant data on the Internet. This approach, which has evolved through interactions with stakeholders, expands the potential respondent community well beyond thedomestic manufacturers (including importers) and processors who would be the only onessubject to any TSCA section 8(a) PAIR or 8(d) reporting requirements. As related in commentsby an HPV Challenge Program participant"Domestic and foreign participants in voluntary programs have agreed to include all relevantunpublished and published data in publicly available 'robust summaries.' Indeed, it is expectedthat more data will be available through the 'robust summaries' which will include collaborativeefforts with foreign producers, than through a Section 8 rule." (Ref. 1)
Further, EPA's implementation of the HPV Challenge Program has involved aproactive approach to increase by collaboration participants. EPA has sent letters to apparent duplicatesponsors notifying them of other participants' commitments and encouraging them to formconsortia or initiate other data sharing efforts thus potentially avoiding duplicative testing bycreating further opportunity to maximize use of existing data. The Agency has established anautomatic e-mail notification feature on its ChemRTK website to update HPV ChallengeProgram information in real time for participants, as well as the public-at-large, thus taking furthersteps to avoid duplicative testing when "new" information becomes available. EPA's approachalso broadens the scope to an international level, considering that many consortia and companiesparticipating in the HPV Challenge Program are coordinating their data collection efforts on aglobal basis and are obtaining studies from companies and other sources throughout the world.EPA agrees with the Environmental Defense statement in their comments (Ref. 2) that "Evenassuming arguendo that any appreciable quantity of unpublished exculpatoryinformation actually exists there is every reason to believe that such information will be madeavailable in the voluntary [HPV Challenge] program." EPA also agrees with HPV participantstatements that they ". . . will not initiate new testing without thoroughly evaluating the need forsuch testing based on review of published and unpublished data. . . . In this highly competitivemarket, companies cannot afford to waste limited resources in conducting unwarranted orunnecessary testing; it is too costly." (Ref. 1)
B. Submissions Under the Requested Regulations Would Substantially Duplicate Data that HPV Challenge Program Participants Already have an Incentive to Provide
EPAbelieves the requested TSCA sections 8(a) PAIR and 8(d) regulatory actions are not necessary inorder to obtain relevant existing hazard test data for chemicals included in the HPV ChallengeProgram because these data will be submitted (to the extent they exist) by participants and othersunder the HPV Challenge Program and by respondents to any associated TSCA section 4 rule(s).EPA believes that for the chemicals sponsored under the HPV Challenge Program, the dataobtained via the requested TSCA sections 8(a) PAIR and 8(d) regulatory actions wouldsubstantially duplicate the extant data that program participants have already committedthemselves to provide voluntarily under the HPV Challenge Program (where such data exist),and thus these actions would not supplement the program in a meaningful way. EPA also isguided by TSCA section 8(a)(2) which states that "To the extent feasible, the Administrator[EPA] shall not require . . . any reporting which is unnecessary or duplicative." As a furthersafeguard to avoid unnecessary testing, EPA encourages anyone (including companies notparticipating in the HPV Challenge Program as well as any other person) having relevant"positive" or "negative" hazard test data to submit such data during the 120-day review period fortest plans as specified in the EPA letter of October 14, 1999.
A fundamental component of the HPV Challenge Program from its inception hasbeen the principle that extant "positive" or "negative" test data should be submitted in order tosatisfy specified program data needs and thereby obviate the need for certain testing under theprogram. This principle has been clearly stated from the initiation of the program (seehttp://www.epa.gov/chemrtk). Further, EPA developed detailed guidance for programparticipants to use when searching for existing hazard test data (seehttp://www.epa.gov/chemrtk/srchguid.htm). HPV Challenge Program participants have formallycommitted to prepare and make available for public inspection test plans that will include extanthazard test data in the form of "robust" (i.e. detailed) summaries before any needed new testing isinitiated (see http://www.epa.gov/chemrtk). The content of these summaries has been acceptedand adopted by the International Organization for Economic Cooperation and Development (OECD) for its Screening Information Data Set (SIDS) Program(for a description of the OECD HPV SIDS Program see http://www.oecd.org/ehs/HPV.htm).
HPV Challenge Program participants and other entities that would be subject to theassociated TSCA section 4 test rule(s) have a strong incentive to provide the needed datavoluntarily (if such data exist), and in particular where such data support a conclusion that someor all of the proposed testing is not necessary. Such responses have occurred with past TSCAsection 4 test rules. The petitioners present no reason to support a presumption that chemicalproducers would not respond similarly in this case. By providing these extant hazard test datavoluntarily, companies recognize that they will save themselves both money and time (see, e.g.,Refs. 1, 3, 4).
EPA intends to consider including HPV chemicals that remain unsponsored in oneor more TSCA section 4 test rules. Comments relating to the use of TSCA section 8 informationgathering rules have been raised previously in association with developing TSCA section 4 testrules. The Agency previously responded ". . . that these sections of TSCA have served as usefultools in the gathering of production, release, health effects, and safety information for manyprevious test rule candidates. . . . However, the use of the rulemaking authorities under TSCAsection 8 for information gathering purposes is not required prior to conducting rulemakingpursuant to TSCA section 4. . . and conventional rulemaking would not have produced section8(a) and (d) data on a timely basis. Furthermore, any available studies could have beensubmitted to EPA in response to the proposed section 4 rule" published in the Federal Register of June 15, 1988 (53 FR 22300, 22304). Thus, based on its past experience in implementingTSCA section 4 rules, EPA believes that potentially regulated persons will have a strong incentiveduring any proposed HPV rule comment period to submit any existing data, of whichthe Agency may not be aware, that are relevant to the specified test rule endpoints. In so doing,these persons may demonstrate to EPA that proposed testing on a particular endpoint for achemical is not needed, and EPA may eliminate such testing from the rule.
C. The Requested Regulations Would be a Less Effective and Efficient Means to Gather Extant Screening-level Hazard Data on HPV Chemicals than the HPV Challenge Program, which is Similar to the Internationally Accepted OECD SIDS Program
Over the past several years,EPA and the regulated community have expressed a general preference for voluntary approaches,where feasible, in data gathering under TSCA (as opposed to regulatory approaches, such as theregulations requested by this petition). The voluntary HPV Challenge Program represents one ofthe most successful voluntary programs to collect chemical toxicity and fate data ever developedby EPA in cooperation with industry and others. To date, the HPV Challenge Program hasresulted in commitments by 437 companies, acting individually or through 155 consortia, toprovide basic toxicity and fate information on 2080 HPV industrial chemicals, either bysubmitting extant data in the form of "robust" summaries, or by agreeing to conduct testingwhere extant data are not available. The success of the HPV Challenge Program is due to thebenefits that accrue under voluntary programs that would not be available under regulatoryapproaches. These benefits include but are not limited to: Less resource intensive, less adversarial,needed information will be submitted sooner and will be available to the public sooner, and stakeholdersare provided more effective interactive input than a similar program developed solely viaregulatory means.
EPA believes that the success of the HPV Challenge Program could be undermined by the promulgation of the requested TSCA sections 8(a) PAIR and 8(d) rules, which, asdescribed in Unit III.B. would largely duplicate data that companies have already committed toprovide voluntarily under the program, and which could also delay the program significantly dueto the time needed to promulgate the regulations (potentially years), permit an industry response,and allow EPA to review the information. For example, if a TSCA section 8(d) rule waspromulgated for all HPV Challenge Program chemicals, the rule would require the submission of completecopies of all unpublished health and safety studies for program chemicals, rather than "robust"summaries of existing studies as required in the HPV Challenge Program. Given the scope of theprogram, the standardized format for "robust" summaries is a much more useful format foraccess and review by EPA and others, including the public-at-large for purposes of the program. By contrast, with a TSCA section8(d) rule, the Agency would have to manage the information, complete a full review of thestudies, and extract the "robust" summary type information on its own at substantial taxpayercost. In addition, the data will be more quickly and easily, accessible, searchable and useableunder the HPV Challenge Program because they will be submitted electronically in astandardized format, whereas they would be submitted primarily in hard copy in anunstandardized format under the requested regulation.
A regulatory approach to data collection could further delay the HPV ChallengeProgram information collection and review because a TSCA section 8(d) rule would require thesubmission of existing health and safety studies beyond those that would be useful in eliminatingdata needs from the HPV Challenge Program. For example, with respect to the requested TSCAsection 8(d) rule, studies of mixtures that contain a substance included in the rule wouldgenerally have to be reported (40 CFR 716.10(a)(2)), and the rule would result in duplicativesubmissions if several manufacturers submit copies of the same study. Yet these additionalstudies would also need to be reviewed by the Agency even though they would not have thepotential to affect the program. As a result of these and other difficulties, EPA agrees with theChemical Manufacturers Association's (CMA's) comment that "the requested actions wouldundermine industry's ability to complete the work already underway in the HPV ChallengeProgram" (Ref. 3).
EPA's experience in implementing the OECD HPV SIDS Program in the United States hasindicated that past efforts to bring forward extant hazard test data have been successful. Similarto the HPV Challenge Program, companies sponsoring SIDS chemicals frequently form consortiaor collaborative panels and thus gain access to studies that may be held by other companies inother countries. Neither EPA nor the petitioners have identified any instance in the OECD HPVSIDS Program where proposed testing, subsequently performed, was later found to be duplicativeof existing adequate test data.
Likewise, the International Council of Chemical Associations (ICCA) hasdemonstrated the willingness of industry to provide existing test data in order to satisfyscreening-level data needs. This organization, which is also implementing a program that issimilar to the HPV Challenge Program, will make existing data held by international companiesavailable for public use (Ref. 5).
EPA believes that the HPV Challenge Program must be given an opportunity towork before regulatory requirements are imposed. This belief is shared by the HPV ChallengeProgram participants, some of whom have stated that "From a time, cost and animal useperspective, the HPV Challenge Program represents the most efficient means yet devised toensure the evaluation of existing chemical substances, and it must go forward in parallel withother similar international programs" (Ref. 3). EPA fully anticipates that the HPV ChallengeProgram will result in the submission of relevant extant hazard test data on the chemicalsincluded in the program.
The HPV Challenge Program is similar in many ways to the voluntary OECD HPVSIDS Program. The OECD HPV SIDS Program is widely acknowledged to be a successfulvoluntary program that is internationally supported by 29 countries, including the United States. It isconsidered by those countries to be fully adequate for purposes of an initial assessment ofchemical hazards. Further, EPA believes that pursuing development of TSCA sections 8(a)PAIR and 8(d) rules would require reporting of little relevant information beyond that obtainedunder the HPV Challenge Program as it is now structured. Compelling the submission of entirestudies under a section 8(d) rule would place on EPA the burden of reviewing the studies,compiling summaries and making the summaries available to the public. Such an approach could potentially take months or years to accomplish, impose substantial costs on EPA withlittle likely benefit accruing to the HPV Challenge Program while unnecessarily delaying the program'sgoal of making screening-level hazard data on HPV chemicals publicly available. EPA also believes that there should be no further unnecessary delay collecting data under the HPV Challenge Program and making the data publicly available, and that it is in the public interest to proceed expeditiously with the HPV Challenge Program.
For the foregoing reasons, EPA is denying the petitioners' request. Although theAgency has decided to deny the petition, EPA recognizes that it may in the future have alegitimate need for information that can be obtained via TSCA section 8(a) PAIR and/or TSCA section 8(d) rules, for example, e.g., in order to support the development of future test rules for chemicals for which the Agency cannot base a finding under TSCA section 4(a) on currently available hazard or exposure-related information.
IV. Comments Received
EPA received many comments in response to the Federal Register noticeannouncing EPA's receipt of this TSCA section 21 petition. EPA considered all commentsreceived by February 23, 2000, in determining the proper response to the petitioners' requests.The majority of the comments were from individuals, most of whom identified themselves asmembers of one or more of the petitioning organizations. These comments urged EPA to grantthe petition, but, generally did not provide additional support for the requested action beyond therationales expressed in the petition itself. The United States Humane Society (Ref. 6) didpresent some additional reasons to support granting the petition. These comments which pertainprimarily to the perceived limitations of the voluntary submission of extant data and the need forEPA to collect positive as well as negative extant data prior to the conduct of testing under theHPV Challenge Program are addressed throughout Unit III. (Ref. 6).
In addition, CMA, the Chemical Specialties Manufacturers Association (CSMA), theSoap and Detergent Association (SDA), the American Petroleum Institute (API), the Great LakesChemical Corporation (GLCC), the Silicones Environmental, Health and Safety Council(SEHSC), the Synthetic Organic Chemicals Manufacturers Association (SOCMA), ElfAtochem(ATO) , and Environmental Defense all urged EPA to deny the petition in its entirety.These comments generally express the view that the "Framework" and design of the HPVChallenge Program will fulfill the need to make existing hazard test data available. CMA,CSMA, SDA, API, GLCC, SEHSC, SOCMA, ATO, and Environmental Defense presented anumber of arguments in support of denying the petition.
All of the comments received by EPA on the petition are located in the officialrecord, as described in Unit I.B.2.
V. References
1. Comments of Elf Atochem North America, Inc. February 2, 2000.
2. Comments of Environmental Defense. February 3, 2000.
3. Comments of the Chemical Manufacturers Association. February 2, 2000.
4. Comments of the Chemical Specialties Manufacturers Association. February 3,2000.
5. International Council of Chemical Associations. Description of High Production Volume (HPV) Chemicals Initiative. http://www.icca-chem.org/hpv/. 2000.
List of Subjects
Environmental protection.
Dated: March 30, 2000.
Susan H. Wayland,
Acting Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances.
[FR Doc. 00-8543 Filed 4-5-00; 8:45 am]
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