OFFICE OF MANAGEMENT AND BUDGET

5 CFR Part _______

RIN __________

Standards for Agency Regulations Governing Data Quality

AGENCY: Office of Management and Budget

ACTION: Proposed Rule.



SUMMARY: The Office of Management and Budget ("OMB") is proposing a rule to set forth what agencies must do to ensure the quality of information used as the basis for agency decision or disseminated within the Government or to the public, as well as to provide a procedural mechanism for correcting defects in such data.

DATES: Comments must be received by ________________, 2000.

ADDRESSES: Send written comments to _________________, Office of Management and Budget, Dwight D. Eisenhower Executive Office Bldg., 17th St. & Pennsylvania Ave., NW, Room ______, Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: _____________________.

TABLE OF CONTENTS:
Supplementary Information 2
1. Statutory requirements 2
2. Identification of substantive standards for data quality
a. Quality.
b. Objectivity.
c. Utility.
d. Integrity.
4
3. Identification of standard to govern petition procedures 7
4. Identification of standard for access to the right to petition
a. Stakeholders under ExecutiveOrder No. 12866.
b. Stakeholders under the Small Business Regulatory Enforcement Fairness Act.
c. Stakeholders under the Unfunded Mandates Reform Act.
d. "Zone of interests" test under the APA.
e. "Adversely affected" party test under the APA.
f. "Aggrieved party" test under the Hobbs Act.
g. Standing under the National Environmental Protection Act.
8
5. Policy considerations
a. Public interest.
b. "Agency capture."
c. Reinventing Government initiative and the question of accountability.
14
6. Review of this Proposed Rule pursuant to applicable law 15
Text of Proposed Rule 16

SUPPLEMENTARY INFORMATION:

1. Statutory requirements. Pursuant to the Paperwork Reduction Act of 1995 ("the Act"), 44 U.S.C. 3501, et seq., and as directed in the House Report accompanying the fiscal year 1999 Omnibus Appropriations Act, P.L. 105-277 (incorporated into the Joint Explanatory Statement), OMB is obligated to promulgate a regulation to ensure the quality of data created, funded or used by Federal agencies. OMB is obligated to include in the regulation a petition process to enable parties to correct inaccuracies in data identified by members of the public. OMB is further obligated to ensure that Federal agencies promulgate conforming regulations so that interested or affected parties will have an effective opportunity to correct such defective data. See H. R. REP. NO. 105-592, 105th Cong., 2d Sess. 47-49 (1998); and CONF. REP. JOINT EXPLANATORY STATEMENT, 144 CONG. REC. H11,508 (Oct. 19, 1998).

Congress has expressly stated that these obligations are in fulfillment of OMB's obligations under the Paperwork Reduction Act. In particular, under the Act OMB is obligated to develop and oversee the implementation of uniform Federal agency guidelines governing Federal information. Id. 3504(a)(1)(A). In fulfilling these obligations, OMB is required to provide interested agencies and persons early and meaningful opportunity to comment. Id. 3517(a).

OMB recognizes that the need for a regulation ensuring Federal data quality has become more pressing during the past decade, as Federal agencies increasingly rely on Internet dissemination as a means, not only of providing Federal data to the public at large, but as a means of 'encouraging' regulated parties to meet agency expectations or preferences before such expectations or preferences are codified and promulgated as final rules in accordance with the procedural protections of the Administrative Procedure Act, P.L. 89-554, 5 U.S.C. 551, et seq. ("APA").

The need for the regulation set forth in this NPRM was perhaps best illustrated by the case of Tozzi v. EPA, No. 98CV-00169 (D.D.C. 1998), in which a petitioner challenged alleged defects in data disseminated by the EPA in connection with the Sector Facility Indexing Program. Although the data quality and standing issues raised by that lawsuit were not finally resolved due to EPA's agreement to withdraw certain of the challenged data, OMB recognizes that today's Proposed Rule would establish a more effective and administratively efficient mechanism for resolving data quality disputes.

2. Identification of substantive standards for data quality. A number of recent commentators have written on the substantive components of data quality and the problem of bias in the context of Federal regulatory decisionmaking. See, e.g., Judge Patricia Wald, Judicial Review of Economic Analyses, 1 Yale J. on Reg. 43 (1983); James Wilson, Methodologies as Rules: Computer Models and the APA, 20 Colum. J. of Law & Social Policy 167 (1986); Federal Focus, Inc., A Blueprint for Constructing a Credible Environmental Risk Assessment Policy in the 104th Congress (1991). The substantive standards set forth in this Proposed Rule are intended to address the concerns raised by these commentators, as well as to provide a clear and objective legal standard for determining whether data is of sufficient quality to justify its use as the basis for decisionmaking or dissemination on the Internet. As mandated by Congress, and as is set forth in the Proposed Rule, "data quality" has four components:

a. Quality. "Quality" generally connotes "accuracy," in the sense of conformance to fact. Thus, conformity to fact should be the bedrock of any data quality requirement with respect to any type of data.

In the context of scientific, research, and statistical data activities, "quality" also includes the requirements that:

(i) agency information arises from a soundly-designed study using appropriate research practices which produces results that are accurate, internally consistent, and valid; and

(ii) the data is transparent in that all assumptions, hypotheses, defaults, and data gaps are clearly defined and explained.

Quality is a broad term that can encompass a range of aspects. Although the Proposed Rule does not expressly require data quality scoring, the greater the emphasis accorded to the following factors, the more likely the information is to meet the quality requirement:

(i) Accuracy: Information is precise and can be verified by an objective, authoritative standard.

(ii) Comparability: Similar information should be structured so as to facilitate review and analysis across data sets.

(iii) Impartiality: In providing scientific information, there should be fair treatment in all aspects of study design and execution.

(iv) Representativeness: Data elements which are part of a study should provide a fair and accurate picture of the universe of potential subjects.

(v) Validity. Agency data should represent a true value of those measures it is designed to measure.

b. Objectivity. A fundamental principle adopted in this Proposed Rule is that Federal data is deemed to be "objective" if it is not presented in a biased or misleading manner, in particular with reference to data pertaining to differently or similarly situated parties. With respect to scientific, research, or statistical data, this Proposed Rule adopts the additional requirements that:

(i) the data must be the result of rational and methodical research or analysis; and

(ii) the data must exist as a fact independent of the expectations of researchers or their subjects.

With respect to research results, it is also required that the results be substantially reproducible by persons with levels of expertise similar to the level of expertise of the persons who created the data, upon independent analysis of the underlying data.

The Proposed Rule also establishes guidelines for documentation. Specifically, creators of information should be meticulous in their documentation. All aspects of study design and execution should be clearly articulated, and all areas of uncertainty and contradiction should be carefully explained, so as to assist in validation of results by peer reviewers and other interested parties.

c. Utility. Under the Proposed Rule, the "utility" requirement would be met if the intended users are reasonably able to use the data for the stated purpose or purposes for which the data is created, obtained, funded, or disseminated, including the ability of such persons to process the data in a timely and useful fashion. With respect to data to be used by an agency, the Proposed Rule states that data would not meet the "utility" requirement unless the data is necessary to achieve a result within the statutory, programmatic, or policy requirements of the agency, and would be used on a timely basis. With respect to scientific, research, or statistical data, "utility" includes the requirement that the agency or other intended users of the data would be able to use the relevant information, including statistical or analytical models, and particularly to process such data in a fashion that is timely, useful, and sufficiently clear as to produce results which can be replicated.

This Proposed Rule adopts a "utility" standard that comports with the "public utility" standard set forth in the Paperwork Reduction Act. Under that standard an agency must have the capability to use the data in pursuit of a valid agency purpose and in a timely fashion. See 44 U.S.C. 3502(11), 3506(c)(3)(A).

d. Integrity. Data "integrity" raises issues of security and bias. Under this Proposed Rule, data would meet the "integrity" requirement if it is whole, secure, and unimpaired by any bias or other condition that would compromise its validity. With respect to scientific or research data, the data would have to manifest or contain an impartial evaluation of the relevant science. In addition, the analysis of the data could not be infused with policy decisions, such as the adoption of "conservative" upper-bound numerical estimates or other worst-case scenarios.

In the scientific community, data is generally considered to be unbiased when it is based on the best available scientific, technical or other data which would produce the most accurate, "real world" results.

As regards data security, examples of data security problems include breaches of computer files by unauthorized parties who then corrupt existing data, and unethical falsification of data by researchers. Thus, appropriate "fire-walls" and other protective measures are often required to assure data integrity.

OMB solicits comments regarding the definitions and standards for the four components of data quality set forth in this NPRM. In particular, OMB is interested in any variations or elaborations to the above standards that would apply to particular types of data.

3. Identification of standard to govern petition procedures. In developing the petition process set forth in this Proposed Rule, OMB reviewed approximately 143 existing petition processes currently implemented by the Environmental Protection Agency ("EPA"). These existing petition process are itemized and discussed in a report issued by The Center for Regulatory Effectiveness entitled, "Petition Processes as a Mechanism for Providing Due Process to the Regulated Community: a Survey of the Environmental Protection Agency" ("the CRE report"), and available for public review at www.theCRE.com. Common elements of existing Federal agency petition processes include the following:

(i) They are generally open to any "interested," "concerned," or "affected" party.

(ii) As long as the petition is in writing and sets forth certain key elements (such as challenged agency action, why the action is allegedly wrongful, the impact on petitioner, and the relief sought), no particular form or format is mandated.

(iii) The agency's disposition of the petition (e.g., granting, denying, or unreasonable delay in responding to the petition) constitutes a "final agency action" subject to judicial review under the APA.

The petition procedure set forth in this Proposed Rule contains the following elements:

(i) A party must be "interested in" or "affected by" (as defined) the Federal data at issue in order to have the right to file a petition.

(ii) The petition must be in writing and set forth certain elements specified in the Proposed Rule.

(iii) The agency must comply with certain "timing of response" requirements.

(iv) Whole or partial denial of a petition is deemed "final agency action" subject to judicial review to the extent provided under the APA.

OMB invites comments regarding the appropriateness of the procedural mechanism set forth in this Proposed Rule, as well as any proposed alternative procedures.

4. Identification of standard for access to the right to petition (i.e., administrative standing). This regulation is designed to protect any and all parties "interested in" or "affected by" Federal data. Although a significant number of the petition processes cited in the CRE report are open to "concerned," "interested," or "affected" parties, none of the regulations provide a global definition of these terms. The definitions set forth in this NPRM take into account the legal precedents described immediately below. OMB invites comments regarding the appropriateness of the definitions set forth herein, as well as comments regarding precedents to be used to establish which parties should have access to the petition process.

In particular, OMB has identified the following legal precedents which indicate the categories of persons and entities that are directly affected by the dissemination or use of Federal data:

a. Stakeholders under Executive Order No. 12866. Executive Order No. 12866, "Regulatory Planning and Review," establishes principles to be followed by Federal agencies in planning and developing regulations. The Executive Order recognizes that members of the public, private-sector entities, and State, local, and tribal governments may be "affected" when a regulatory action will have any of the following impacts:

(i) material or adverse effect on a distinct sector of the economy;

(ii) material or adverse effect on productivity, competition, or jobs;

(iii) material or adverse effect on the environment or public health or safety;

(iv) material or adverse effect on State, local, or tribal government;

(v) serious inconsistency with action taken by another Federal agency; or,

(vi) material budgetary impact on entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof.

See Exec. Order No. 12866 3(f); see also id. 6(a)(2)(C).

The Executive Order also calls upon agencies to work with those who are intended to benefit from or be burdened by planned regulatory actions. Id. 6(a)(1).

The precedent established by the Executive Order suggests that, by way of illustration and not limitation, the following persons, business entities, or governmental entities should have access to the data quality petition process set forth in this NPRM if any of the following conditions are present:

(i) a manufacturer of or dealer in a product or service, if the Federal data is intended to be used to regulate the manufacture or marketing of that product or service;

(ii) an individual who works or employs in a specific sector of the economy, if the Federal data is intended to be used to regulate that sector in a manner that could reasonably be expected to materially or adversely affect productivity, competition, or jobs in that sector;

(iii) the Federal data is intended to be used to regulate the environment or public health or safety, and the ultimate use of the Federal data would have a direct impact on the petitioner, due to the petitioner's health condition, activities, location, or actual use of a localized environmental resource;

(iv) the Federal data is intend to be used to make a decision that will have a material or adverse effect, budgetary or otherwise, on a State, local, or tribal government, and the petitioner is a State, local, or tribal governmental entity or instrumentality;

(v) the Federal data is significantly inconsistent with other data available to the agency, and the Federal data pertains to the petitioner;

(vi) the Federal data is intended to be used for decisionmaking with respect to entitlements, grants, user fees, or loan programs, and the petitioner's status as a recipient or obligor would be affected by the ultimate decision; or

(vii) the petitioner is intended to benefit from or be burdened, or otherwise directly affected, by actions based wholly or partly on use of the Federal data.

b. Stakeholders under the Small Business Regulatory Enforcement Fairness Act. The Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 801, et seq., recognizes the following additional categories of impacts that can directly affect classes of stakeholders, suggesting that these types of impacts should give rise to stakeholder status for purposes of data quality petitions:

(i) major increases in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or

(ii) significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets.

See id. 804(2)(B), (C).

Accordingly, the following additional categories of persons should have access to the petition process set forth in this NPRM if allegedly defective Federal data is intended to be used, either by the Federal Government or by other data users (e.g., as a result of dissemination of the Federal data on the Internet), in a manner that would adversely affect such parties:

(i) consumers, manufacturers, or providers of goods or services to be regulated based on Federal data; and

(ii) businesses, or organizations representing such businesses, that stand to suffer adverse competitive impacts are a result of the dissemination or use of allegedly defective data.

c. Stakeholders under the Unfunded Mandates Reform Act. The Unfunded Mandates Reform Act ("UMRA"), P.L. 104-4, 2 U.S.C. 658, et seq., 1501, et seq., establishes procedures to be followed by Congress and Federal agencies when enacting or promulgating legislation or regulations imposing "mandates" that would, in turn, impose costs on the private sector or on State, local, or tribal governments. UMRA applies to proposed legislative or regulatory provisions that would "impose enforceable duties" or "direct costs." See 2 U.S.C. 658(3), (5) (UMRA 421(3), (5)). This legal precedent suggests that, where the Federal data is intended to be used to plan, develop or promulgate a regulation that would impose mandates or costs directly on a person or entity, that person or entity should have standing to file a data quality petition.

d. "Zone of interests" test under the APA. The judicial review provision of the APA has been interpreted by the United States Supreme Court as embodying two standing requirements of relevance to this NPRM before a petitioner will be entitled to judicial review of a "final agency action," including a final rule. First, under the "zone of interests" test, a petitioner has standing only if it is determined, based on analysis of the language or legislative history of the relevant underlying statute, that Congress intended the petitioner to have access to judicial review. See, e.g., Lujan v. National Wildlife Fed'n, 497 U.S. 871 (1990). OMB has determined that this test does not provide meaningful guidance for use in establishing a threshold for access to the data quality petition procedure, because: (i) it would be administratively impracticable for each agency to engage in a separate legislative history analysis with respect to each type of petitioner whenever a petition is filed; and (ii) the "adversely affected" party test (discussed immediately below) provides a threshold more appropriate threshold.

OMB invites public comment as to whether the "zone of interest" test provides any useful precedential guidance that could be applied in determining which classes of petitioners should have access to the data quality petition process set forth in this NPRM.

e. "Adversely affected" party test under the APA. The "adversely affected" party test is the second test applied by the United States Supreme Court in order to determine whether a petitioner has standing under the APA. See, e.g., Animal Legal Defense Fund v. Quigg, 932 F.2d 920, 925 (Fed. Cir. 1991). As this test is similar in nature to the stakeholder standards in the regulatory statutes discussed at "a" through "c" immediately above, OMB believes that judicial application of this test provides helpful guidance in determining which types of petitioners are sufficiently "affected" or "concerned" by a given set of Federal data so as to justify allowing them standing to file data quality petitions.

(i) Direct economic injury; direct impairment of health or safety. Where the use, funding, or dissemination of Federal data is reasonably likely to have a direct economic, health, or safety impact on the petitioner, there is a strong case for standing. Cf., e.g., McClellan Ecological Seepage Situation (MESS) v. Cheney, 763 F. Supp. 431, 438 (E.D. Cal. 1989), vacated on other grounds, 47 F.3d 325 (9th Cir. 1994), cert. denied, 516 U.S. 807 (1995).

(ii) Competitive injury. Where the use or dissemination of defective Federal data would result in decisions that would affect a business' competitive position or sales, that person should have standing under the Proposed Rule to file a data quality petition. See, e.g., Scheduled Airlines Traffic Offices, Inc. v. Department of Defense, 87 F.3d 1356, 1359 (D.C. Cir. 1996); Associated Gas Distrib. v. FERC, 899 F.2d 1250, 1258 (D.C. Cir. 1990).

(iii) Consumer injury in connection with regulated products and services. Where the petitioner is a user of a product or service, and Federal decisionmaking would have an impact on the cost or quality of the product or service, the petitioner should have standing. See, e.g., ANR Pipeline v. FERC, 771 F.2d 507, 515-16 (D.C. Cir. 1985); Office of Communication v. FCC, 359 F.2d 994, 1002 (D.C. Cir. 1966). This type of standing is particularly important where public ratemaking activities are involved. For example, it periodically occurs that a member of the public is willing to challenge a regulatory proposal that favors a large public utility against the interests of the general public, where no other company or public interest group is willing or able to make the challenge. See id. These precedents indicate that such "consumer standing" should be recognized whenever the use or dissemination of Federal data will affect decisions, Federal or private, with respect to regulated products or services.

(iv) Reputational injury. Injury to a person's reputation, commercial or otherwise, is a recognized predicate for standing. See, e.g., Joint Anti-Fascist Refugee Comm. v. McGrath, 341 U.S. 123 (1951). Under the Proposed Rule a person who is the subject of inaccurate Federal data would have standing to require the agency to clear his, her, or its name.

f. "Aggrieved party" test under the Hobbs Act. The Hobbs Act, 28 U.S.C. 2342, 2344, provides direct Federal Circuit Court review of the orders of certain enumerated Federal agencies. Standing decisions under the Hobbs Act are in line with those under the APA, as well as with the standing provision in this Proposed Rule, in that they require that the petitioner be "aggrieved" and that the petitioner must have participated in any open, publicly-noticed rulemaking process that gave rise to the challenged decision. See, e.g., JEM Broadcasting Co., Inc. v. FCC, 22 F.3d 320, 324-26 (D.C. Cir. 1994); Wales Transp., Inc. v. Interstate Commerce Comm'n, 728 F.2d 774, 776 n.1 (5th Cir. 1984). The Hobbs Act precedents indicate that the approach taken in the present Proposed Rule is consonant with existing jurisprudence on standing, both administrative and judicial.

g. Standing under the National Environmental Policy Act. Under the National Environmental Policy Act ("NEPA"), 42 U.S.C. 4321, et seq., an individual has standing to sue to compel compliance with the statute's environmental impact statement ("EIS") requirement where he or she uses an environmental resource and such use is threatened by a planned activity that would have a significant impact on the environment. In addition, standing is recognized under NEPA where the petitioner lives in the vicinity of a potential new environmental hazard. See, e.g., Greenpeace USA v. Stone, 748 F. Supp. 749, 755-56 (D. Hawaii 1990), appeal dismissed, 924 F.2d 175 (9th Cir. 1991); Oregon Envtl. Council v. Kunzman, 817 F.2d 484, 491 (9th Cir. 1987) (requiring "sufficient geographical nexus to the site of the challenged project"). These precedents suggest that data quality standing should be recognized whenever the use or dissemination of Federal data will be used to make decisions that will affect the environment of the location in which the petitioner lives or works, or will affect an environmental resource actually used by the petitioner (e.g., a public lake).

5. Policy considerations. This Proposed Rule is based on the following public policy considerations:

a. Public interest. Government and the public have a shared interest in ensuring data quality. Quality data is the basis for sound regulations to protect the public. Quality data protects against the waste of taxpayer-funded Federal resources.

b. "Agency capture." One aspect of the public interest is the avoidance of "agency capture." Under this judicially recognized phenomenon, Federal agency decisionmaking may be skewed due to the fact that one "faction" representing one policy perspective dominates the rulemaking process, sometimes due to personnel factors within the agency. According to one commentator, "adoption of an inclusive approach to administrative law standing" is a key factor in remedying and preventing the problem. See Kenneth Culp Davis, Administrative Law Treatise 16.11 at 68-69; see also, Federation for Am. Immigration v. Reno, 93 F.3d 897, 902-03 (D.C. Cir. 1996) (where there is the danger that "powerful domestic interest groups" could have a "distorting influence over the relevant agencies," it becomes more appropriate to lower the standing bar so as to allow standing to "champions who have near-universal interests (breathing clean air, for example)"). Allowing broad administrative law standing to all affected or concerned members of the public ensures that "[a]gencies become aware of the broad effects of their actions on consumers, race relations, the environment, etc." Davis, supra, at 70. The petitioner standing provision in this Proposed Rule attempts to strike a balance between the need for broad public access and the administrative requirement that access be limited to petitioners with some reasonable nexus to the Federal data at issue, which is necessary to avoid nuisance petitions.

c. Reinventing Government initiative and the question of accountability. OMB believes that the petition process set forth in this NPRM will promote and reinforce the Administration's efforts in connection with its Reinventing Government initiative, and will improve Federal Government accountability to the public as a general matter.

OMB invites public comment identifying other public policy concerns that should be taken into account in developing a final rule, as well as on the specific revisions to the Proposed Rule that would address such policy concerns.

6. Review of this Proposed Rule pursuant to applicable law.

a. Regulatory Flexibility Act. I certify that this Proposed Rule will not have a significant economic impact on a substantial number of small entities.

Office of Management and Budget.
Jacob Joseph Lew,
Director,

Accordingly, OMB is amending Part ___ of title 5 of the Code of Federal Regulations by adding the following Subpart _____ as follows:

SUBPART _____ - STANDARDS FOR AGENCY REGULATIONS GOVERNING DATA QUALITY

1. Applicability. This rule applies to all Federal agencies subject to the Paperwork Reduction Act of 1995.

2. Definitions.

a. "Conforming rule." The term "conforming rule" or "conforming agency rule" means the regulation to be promulgated by each Federal agency, pursuant to 3 of this regulation.

b. "Data." The term "data" includes information.

c. "Data quality petition." The term "data quality petition" means a petition filed pursuant to 4.c of this rule.

d. "Defect." With respect to Federal data, "defect" means the noncompliance of an item of data with one or more of the requirements set forth in 4.b of this rule.

e. "Defective data." Defective data means data that contains one or more defects.

f. "Federal agency." "Federal agency" means an agency as defined at 5 U.S.C. 551(1).

g. "Federal data." "Federal data" means any information or data created, funded, used, or disseminated by, or caused to be created, funded, used, or disseminated by, a Federal agency.

h. "Integrity." Data possesses the component of "integrity" if it complies with the standard set forth at 4.b(iv) of this rule.

i. "Objectivity." Data is "objective" if it complies with the standard set forth at 4.b(ii) of this rule.

j. "Person." "Person" means a "person" as defined at 44 U.S.C. 3502(10).

k. "Quality." Data possesses the component of "quality" if it complies with the standard set forth at 4.b(i) of this rule. "Data quality" exists, however, only if the requirements of all four of the components of 4.b are met.

l. "Utility." Data possesses the component of "utility" if it complies with the standard set forth at 4.b(iii) of this rule.

3. Federal agency rulemaking, implementation, and oversight responsibilities. Each Federal agency shall, within nine months of the publication of this regulation as a final rule in the Federal Register, promulgate a final rule to ensure the quality of Federal data created, funded, used, or disseminated (or caused to be created, funded, used, or disseminated) by the agency. The final rule shall conform to the requirements of 3 and 4 of this regulation. Each agency, and in particular the office within the agency responsible for the agency's compliance with the Paperwork Reduction Act (pursuant to 44 U.S.C. 3506(a)(2), (3)), shall bear responsibility thereafter for full implementation and oversight with respect to the agency's conforming rule.

4. Contents of agency data quality rules. The rule to be promulgated by each agency shall contain all of the following provisions:

a. Requirement of data quality. An agency shall not create, use, fund, or disseminate Federal data for any purpose unless the data meets the quality, objectivity, utility, and integrity requirements set forth in subsection "b." An agency shall not cause another party to create, use, fund, or disseminate Federal data unless the agency obtains and implements written assurances that the data will be in compliance with the requirements set forth in subsection "b" of this 4.

b. Standards for data quality.

(i) Quality. Federal data shall be deemed to meet the "quality" requirement if the data is accurate in that it is in conformity to fact. With respect to scientific, research, or statistical data, quality includes the additional requirements that: (A) agency information arises from a soundly-designed study using appropriate research practices which produces results that are accurate, internally consistent, and valid; and (B) the data is transparent in that all assumptions, hypotheses, defaults, and data gaps are clearly defined and explained.

Data is more likely to meet the quality requirement to the extent that the following factors are present:

(A) Accuracy: Information is precise and can be verified by an objective, authoritative standard.

(B) Comparability: Similar information should be structured so as to facilitate review and analysis across data sets.

(C) Impartiality: In providing scientific information, there should be fair treatment in all aspects of study design and execution.

(D) Representativeness: Data elements which are part of a study should provide a fair and accurate picture of the universe of potential subjects.

(E) Validity. Agency data should represent a true value of those measures it is designed to measure.

Data scoring is encouraged where appropriate, but not required in all contexts.

(ii) Objectivity. Federal data shall be deemed to meet the "objectivity" requirement if it is not presented in a biased or misleading manner, in particular with reference to data pertaining to differently or similarly situated parties. With respect to scientific, research, or statistical data, objectivity includes the additional requirements that: (A) the data is the result of rational and methodical research or analysis; and (B) the data exists as a fact independent of the expectations of researchers or their subjects. With respect to research results, objectivity also includes the requirement that the results be substantially reproducible, by persons with levels of expertise similar to the level of expertise of the persons who created the data, upon independent analysis of the underlying data.

In order to ensure objectivity, creators of information should be meticulous in their documentation. All aspects of study design and execution should be clearly articulated, and all areas of uncertainty and contradiction should be carefully explained, so as to assist in validation of results by peer reviewers and other interested parties.

(iii) Utility. Federal data shall be deemed to meet the "utility" requirement if the intended users are reasonably able to use the data for the stated purpose or purposes for which the data is created, obtained, funded, or disseminated, including the ability of such persons to process the data in a timely and useful fashion. With respect to data to be used by an agency, the data shall not meet the "utility" requirement unless it is reasonably expected to achieve a necessary result within the statutory, programmatic, or policy requirements of the agency, and will be used on a timely basis. With respect to scientific, research, or statistical data, "utility" includes the requirement that the agency or other intended users of the data will be able to use the relevant information, including statistical or analytical models, and particularly to process such data in a fashion that is timely, useful, and sufficiently clear as to produce results which can be replicated.

(iv) Integrity. Federal data shall be deemed to meet the "integrity" requirement if the data is whole, secure, and unimpaired by any bias or other condition that would compromise its validity. With respect to scientific or research data, data is unbiased if it manifests or contains an impartial evaluation of the relevant science, and that the analysis of the data is not infused with policy decisions, such as the adoption of "conservative" upper-bound numerical estimates or other worst-case scenarios.

Data shall not be deemed secure, inter alia, if it is or has been subject to security problems such as breach of computer files by unauthorized parties, corruption of the data by unauthorized parties, or falsification.

c. Petition process. The conforming agency rule shall contain a petition process under which an affected or interested party shall be able to file a petition with the agency to correct defective data. The petition process shall contain the following elements:

(i) Contents of petition. The petition shall identify: (A) the petitioner; (B) the challenged Federal data; (C) the alleged defects in the data; (D) the relief sought; and (E) whether the petitioner had, and took advantage of, any opportunity for public comment at the time the challenged data was created or at the time the decision was made to disseminate the data.

(ii) Timing of agency response. The agency shall send the petitioner an acknowledgment of receipt of the petition setting forth the date of receipt. The agency shall resolve the petition within 60 days of the date of receipt, unless the petition alleges immediate or irreparable harm, in which case subsection "c(v)" of this 4 shall govern. If the agency will not be able to respond within 60 days, the agency shall provide notice to petitioner 15 days prior to expiration of the initial 60 day period, setting forth a valid reason beyond the agency's control.

(iii) Availability of judicial review. Agency disposition of a data quality petition shall be deemed a "final agency action" subject to judicial review to the extent allowed under 5 U.S.C. 702 and 706.

(iv) Prior opportunity for public comment. If, prior to the time the challenged Federal data was created, or prior to the time the decision was made to disseminate the data, the agency published a notice in the Federal Register providing all members of the public with a full and complete opportunity to review and comment on the data, including the methodologies and assumptions underlying the creation of the data, a petitioner shall not have standing unless the petitioner filed comments pursuant to such process.

(v) Emergency procedure; interim relief. If the petitioner alleges that the dissemination of defective data is causing, or threatens to cause, immediate irreparable harm, the agency shall immediately desist from such dissemination (including withdrawing existing dissemination) until final resolution of the petition (including any available judicial review). The petitioner shall be liable to the agency, or to persons funded by the agency, for the all costs directly flowing from any interim relief requested by the petitioner and undertaken by the agency (or persons funded by the agency), but only to the extent that the petitioner does not prevail upon final disposition of the petition. If such direct costs are reasonably anticipated to exceed $_______ (based on the sole, unreviewable discretion of the agency), then the petitioner shall be required to post a bond in such amount as a precondition of the provision of such interim relief.

d. Standing to file data quality petitions.

(i) Affected or interested person. A person shall have standing to file a data quality petition pursuant to this regulation if such person is affected by or interested in the Federal data that is the subject of the petition. A person shall be deemed to be affected by or interested in the data, inter alia, if: (A) the data pertains to the person, regardless of whether or not the data identifies the person; (B) there is a reasonable possibility that the way in which the data is created, used, or disseminated has, is, or will adversely affect the person's health, safety, ability to use an environmental resource, economic interest, or reputation; or (C) there is a reasonable possibility that a right or lawful activity of the person has, is, or will be impaired due to the way in which the data is created, used, or disseminated.

(ii) Associational standing. An association or organization shall have standing to file a data quality petition if the one or more of its members are or will be affected by or interested in the creation, funding, use, or dissemination of Federal data.

(iii) Territorial limitation. The petitioner must be United States resident or have significant business activities in the United States. This regulation is not intended to create rights in non-US residents without significant contacts with, or activities in, the United States, even when the non-US activities of such non-US persons may arguably be affected by the creation, use, or dissemination of Federal data.

5. Procedural requirements for agency rulemakings. Each agency shall plan, develop and promulgate its conforming rule in full compliance with 5 U.S.C. 553. Final agency conforming rules (or failure to timely promulgate such rules) shall be subject to judicial review to the extent provided under 5 U.S.C. 702 and 706.