(a) Certification requirement. Each affected wood heater must be certified to be in compliance with the applicable emission standards and other requirements of this subpart. For each model line manufactured or sold by a single entity (e.g., company or manufacturer), compliance with applicable emission standards of Sec. 60.532 must be determined based on testing of representative affected wood heaters within the model line. If one entity licenses a model line to another entity, each entity's model line must be certified. If an entity intends to change the name of the entity or the name of the model, the manufacturer must apply for a new certification 60 days before the intended name change.
(1) Except for model lines meeting the requirements of paragraph (h)(1) of this section, on or after May 15, 2015, the manufacturer must submit to the Administrator the information required in paragraph (b) of this section and follow either the certification process in paragraphs (c) through (e) of this section or the third-party certifier-based application process specified in paragraph (f) of this section.
(2) On or after May 16, 2016, the manufacturer must submit the information required in paragraph (b) of this section and follow the third-party certifier-based application process specified in paragraph (f) of this section.
(b) Application for a certificate of compliance. Any manufacturer of an affected wood heater must apply to the Administrator for a certificate of compliance for each model line. The application must be submitted to: WoodHeaterReports@epa.gov. The application must be signed by a responsible representative of the manufacturer or an authorized representative and must contain the following:
(1) The model name and design number. The model name and design number must clearly distinguish one model from another. The name and design number cannot include the EPA symbol or logo or name or derivatives such as ``EPA.''
(2) Engineering drawings and specifications of components that may affect emissions (including specifications for each component listed in paragraph (k)(2), (3) and (4) of this section). Manufacturers may use assembly or design drawings that have been prepared for other purposes, but must designate on the drawings the dimensions of each component listed in paragraph (k) of this section. Manufacturers must identify tolerances of components listed in paragraph (k)(2) of this section that are different from those specified in that paragraph, and show that such tolerances cannot reasonably be anticipated to cause wood heaters in the model line to exceed the applicable emission limits. The drawings must identify how the emission-critical parts, such as air tubes and catalyst, can be readily inspected and replaced.
(3) A statement whether the firebox or any firebox component (including the materials listed in paragraph (k)(3) of this section) will be composed of material different from the material used for the firebox or firebox component in the wood heater on which certification testing was performed, a description of any such differences and demonstration that any such differences may not reasonably be anticipated to adversely affect emissions or efficiency.
(4) Clear identification of any claimed confidential business information (CBI). Submit such information under separate cover to the EPA CBI Office; Attn: Residential Wood Heater Compliance Program Lead, 1200 Pennsylvania Ave. NW., Washington, DC 20004. Note that all emissions data, including all information necessary to determine emission rates in the format of the standard, cannot be claimed as CBI.
(5) All documentation pertaining to a valid certification test, including the complete test report and, for all test runs: Raw data sheets, laboratory technician notes, calculations and test results. Documentation must include the items specified in the applicable test methods. Documentation must include discussion of each test run and its appropriateness and validity, and must include detailed discussion of all anomalies, whether all burn rate categories were achieved, any data not used in the calculations and, for any test runs not completed, the data collected during the test run and the reason(s) that the test run was not completed and why. The burn rate for the low burn rate category must be no greater than the rate that an operator can achieve in home use and no greater than is advertised by the manufacturer or retailer. The test report must include a summary table that clearly presents the individual and overall emission rates, efficiencies and heat outputs. Submit the test report and all associated required information, according to the procedures for electronic reporting specified in Sec. 60.537(f).
(6) A copy of the warranties for the model line, which must include a statement that the warranties are void if the unit is used to burn materials for which the unit is not certified by the EPA and void if not operated according to the owner's manual.
(7) A statement that the manufacturer will conduct a quality assurance program for the model line that satisfies the requirements of paragraph (m) of this section.
(8) A statement describing how the tested unit was sealed by the laboratory after the completion of certification testing and asserting that such unit will be stored by the manufacturer in the sealed state until 5 years after the certification test.
(9) Statements that the wood heaters manufactured under this certificate will be--
(i) Similar in all material respects that would affect emissions as defined in Sec. 60.531 to the wood heater submitted for certification testing, and
(ii) Labeled as prescribed in Sec. 60.536.
(iii) Accompanied by an owner's manual that meets the requirements in Sec. 60.536. In addition, a copy of the owner's manual must be submitted to the Administrator and be available to the public on the manufacturer's Web site.
(10) A statement that the manufacturer has entered into contracts with an approved laboratory and an approved third-party certifier that satisfy the requirements of paragraph (f) of this section.
(11) A statement that the approved laboratory and approved third-party certifier are allowed to submit information on behalf of the manufacturer, including any claimed to be CBI.
(12) A statement that the manufacturer will place a copy of the certification test report and summary on the manufacturer's Web site available to the public within 30 days after the Administrator issues a certificate of compliance.
(13) A statement of acknowledgment that the certificate of compliance cannot be transferred to another manufacturer or model line without written approval by the Administrator.
(14) A statement acknowledging that it is unlawful to sell, distribute or offer to sell or distribute an affected wood heater without a valid certificate of compliance.
(15) Contact information for the responsible representative of the manufacturer and all authorized representatives, including name, affiliation, physical address, telephone number and email address.
(c) Administrator approval process. (1) The Administrator may issue a certificate of compliance for a model line if the Administrator determines, based on all information submitted by the applicant and any other relevant information available, that:
(1) The Administrator may issue a certificate of compliance for a model line if the Administrator determines, based on all information submitted by the applicant and any other relevant information available, that:
(i) A valid certification test demonstrates that the representative affected wood heater complies with the applicable emission standards in Sec. 60.532;
(ii) Any tolerances or materials for components listed in paragraph (k)(2) or (3) of this section that are different from those specified in those paragraphs may not reasonably be anticipated to cause wood heaters in the model line to exceed the applicable emission limits; and
(iii) The requirements of paragraph (b) of this section have been met.
(2) The Administrator will deny certification if the Administrator determines that the criteria in paragraph (c)(1) of this section have not been satisfied. Upon denying certification under this paragraph, the Administrator will give written notice to the manufacturer setting forth the basis for this determination.
(d) Level of compliance certification. The Administrator will issue the certificate of compliance for the most stringent particulate matter emission standard that the tested representative wood heater meets under Sec. 60.532.
(e) Conditional, temporary certificate of compliance. A conditional, temporary certificate of compliance may be granted by the Administrator until May 16, 2016 based on the manufacturer's submittal of a complete certification application meeting all the requirements in Sec. 60.533(b). The application must include the full test report by an EPA-approved laboratory and all required compliance statements by the manufacturer with the exception of a certificate of conformity by an EPA-approved third-party certifier. The conditional, temporary certificate of compliance would allow manufacture and sales of the affected wood heater model line until May 16, 2016 or until the Administrator completes the review of the application, whichever is earlier. By May 16, 2016, the manufacturer must submit a certificate of conformity by an EPA-approved third-party certifier.
(f) Third-party certifier-based application process. (1) Any manufacturer of an affected wood heater must apply to the Administrator for a certificate of compliance for each model line. The manufacturer must meet the following requirements:
(1) Any manufacturer of an affected wood heater must apply to the Administrator for a certificate of compliance for each model line. The manufacturer must meet the following requirements:
(i) The manufacturer must contract with a third-party certifier for certification services. The contract must include regular (at least annual) unannounced audits under ISO-IEC Standard 17065 to ensure that the manufacturer's quality assurance plan is being implemented. The contract must also include a report for each audit under ISO-IEC Standard 17065 that fully documents the results of the audit. The contract must include authorization and requirement for the third-party certifier to submit all such reports to the Administrator and the manufacturer within 30 days of the audit. The audit report must identify deviations from the manufacturer's quality assurance plan and specify the corrective actions that need to be taken to address each identified deficiency.
(ii) The manufacturer must submit the materials specified in paragraph (b) of this section and a quality assurance plan that meets the requirements of paragraph (m) of this section to the third-party certifier. The quality assurance plan must ensure that units within a model line will be similar in all material respects that would affect emissions to the wood heater submitted for certification testing, and it must include design drawings for the model line.
(iii) The manufacturer must apply to the third-party certifier for a certification of conformity with the applicable requirements of this subpart for the model line.
(A) After testing by an approved test laboratory is complete, certification of conformity with the emission standards in Sec. 60.532 must be performed by the manufacturer's contracted third-party certifier.
(B) The third-party certifier may certify conformity if the emission tests have been conducted per the appropriate guidelines; the test report is complete and accurate; the instrumentation used for the test was properly calibrated; the test report shows that the representative affected wood heater meets the applicable emission limits specified in Sec. 60.532; the quality assurance plan is adequate to ensure that units within the model line will be similar in all material respects that would affect emissions to the wood heater submitted for certification testing; and that the affected heaters would meet all applicable requirements of this subpart.
(iv) The manufacturer must then submit to the Administrator an application for a certificate of compliance that includes the certification of conformity, quality assurance plan, test report and all supporting documentation specified in paragraph (b) of this section.
(v) The submission also must include a statement signed by a responsible official of the manufacturer or authorized representative that the manufacturer has complied with and will continue to comply with all requirements of this subpart for certificate of compliance and that the manufacturer remains responsible for compliance regardless of any error by the test laboratory or third-party certifier.
(2) The Administrator will issue to the manufacturer a certificate of compliance for a model line if it is determined, based on all of the information submitted in the application for certification and any other relevant information, that:
(i) A valid certification of conformity has demonstrated that the representative affected wood heater complies with the applicable emission standards in Sec. 60.532;
(ii) Any tolerances or materials for components listed in paragraph (k)(2) or (3) of this section that are different from those specified in those paragraphs may not be reasonably anticipated to cause wood heaters in the model line to exceed the applicable emission limits;
(iii) The requirements of paragraph (b) of this section have been met; and
(iv) A valid certificate of conformity for the model line has been prepared and submitted.
(3) The Administrator will deny certification if the Administrator determines that the criteria in paragraph (f)(2) of this section have not been satisfied. Upon denying certification under this paragraph, the Administrator will give written notice to the manufacturer setting forth the basis for the determination.
(g) Waiver from submitting test results. An applicant for certification may apply for a potential waiver of the requirement to submit the results of a certification test pursuant to paragraph (b)(5) of this section, if the wood heater meets either of the following conditions:
(1) The wood heaters of the model line are similar in all material respects that would affect emissions, as defined in Sec. 60.531, to another model line that has already been issued a certificate of compliance. A manufacturer that seeks a waiver of certification testing must identify the model line that has been certified, and must submit a copy of an agreement with the owner of the design permitting the applicant to produce wood heaters of that design.
(2) The manufacturer has previously conducted a valid certification test to demonstrate that the wood heaters of the model line meet the applicable standard specified in Sec. 60.532.
(h) Certification period. Unless revoked sooner by the Administrator, a certificate of compliance will be valid for the following periods as applicable:
(1) For a model line that was previously certified as meeting the 1990 Phase II emission standards under the 1988 NSPS, in effect prior to May 15, 2015, at an emission level equal to or less than the 2015 emission standards in Sec. 60.532(a), the model line is deemed to have a certificate of compliance for the 2015 emission standards in Sec. 60.532(a), which is valid until the effective date for the 2020 standards in Sec. 60.532(b) (i.e., until May 15, 2020).
(2) For a model line certified as meeting emission standards in Sec. 60.532, a certificate of compliance will be valid for 5 years from the date of issuance or until a more stringent standard comes into effect, whichever is sooner.
(i) Renewal of certification. (1) The manufacturer must request renewal of a model line's certificate of compliance or recertify the model line every 5 years, or the manufacturer may choose to no longer manufacture or sell that model line after the expiration date. If the manufacturer chooses to no longer manufacture that model line, then the manufacturer must submit a statement to the Administrator to that effect.
(1) The manufacturer must request renewal of a model line's certificate of compliance or recertify the model line every 5 years, or the manufacturer may choose to no longer manufacture or sell that model line after the expiration date. If the manufacturer chooses to no longer manufacture that model line, then the manufacturer must submit a statement to the Administrator to that effect.
(2) A manufacturer of an affected wood heater model line may apply to the Administrator for potential renewal of its certificate of compliance by submitting the material specified in paragraph (b) and following the procedures specified in paragraph (f) of this section, or by affirming in writing that the wood heaters in the model line continue to be similar in all material respects that would affect emissions to the representative wood heater submitted for testing on which the original certificate of compliance was based and requesting a potential waiver from certification testing. The application must include a copy of the review of the draft application and approval by the third-party certifier.
(3) If the Administrator grants a renewal of certification, the Administrator will give written notice to the manufacturer setting forth the basis for the determination and issue a certification renewal.
(4) If the Administrator denies the request for a renewal of certification, the Administrator will give written notice to the manufacturer setting forth the basis for the determination.
(5) If the Administrator denies the request for a renewal of certification, the manufacturer and retailer must not manufacture or sell the previously-certified wood heaters after the expiration date of the certificate of compliance.
(j) [Reserved]
(k) Recertification. (1) The manufacturer must recertify a model line whenever any change is made in the design submitted pursuant to paragraph (b)(2) of this section that affects or is presumed to affect the particulate matter emission rate for that model line. The manufacturer of an affected wood heater must apply to the Administrator for potential recertification by submitting the material specified in paragraph (b) and following the procedures specified in paragraph (f) of this section, or by affirming in writing that the change will not cause wood heaters in the model line to exceed applicable emission limits and requesting a potential waiver from certification testing. The application for recertification must be reviewed and approved by the contracted third-party certifier and a copy of the review and approval must be included. The Administrator may waive this requirement upon written request by the manufacturer, if the manufacturer presents adequate rationale and the Administrator determines that the change may not reasonably be anticipated to cause wood heaters in the model line to exceed the applicable emission limits. The granting of such a waiver does not relieve the manufacturer of any compliance obligations under this subpart.
(1) The manufacturer must recertify a model line whenever any change is made in the design submitted pursuant to paragraph (b)(2) of this section that affects or is presumed to affect the particulate matter emission rate for that model line. The manufacturer of an affected wood heater must apply to the Administrator for potential recertification by submitting the material specified in paragraph (b) and following the procedures specified in paragraph (f) of this section, or by affirming in writing that the change will not cause wood heaters in the model line to exceed applicable emission limits and requesting a potential waiver from certification testing. The application for recertification must be reviewed and approved by the contracted third-party certifier and a copy of the review and approval must be included. The Administrator may waive this requirement upon written request by the manufacturer, if the manufacturer presents adequate rationale and the Administrator determines that the change may not reasonably be anticipated to cause wood heaters in the model line to exceed the applicable emission limits. The granting of such a waiver does not relieve the manufacturer of any compliance obligations under this subpart.
(2) Any change in the design tolerances or actual dimensions of any of the following components (where such components are applicable) is presumed to affect particulate matter and carbon monoxide emissions and efficiency if that change exceeds 0.64 cm (\1/4\ inch) for any linear dimension and 5 percent for any cross-sectional area relating to air introduction systems and catalyst bypass gaps unless other dimensions and cross-sectional areas are previously approved by the Administrator under paragraph (c)(1)(ii) of this section:
(i) Firebox: Dimensions;
(ii) Air introduction systems: Cross-sectional area of restrictive air inlets and outlets, location and method of control;
(iii) Baffles: Dimensions and locations;
(iv) Refractory/insulation: Dimensions and location;
(v) Catalyst: Dimensions and location;
(vi) Catalyst bypass mechanism and catalyst bypass gap tolerances (when bypass mechanism is in closed position): Dimensions, cross-sectional area, and location;
(vii) Flue gas exit: Dimensions and location;
(viii) Door and catalyst bypass gaskets: Dimensions and fit;
(ix) Outer thermal shielding and thermal coverings: Dimensions and location;
(x) Fuel feed system: For wood heaters that are designed primarily to burn pellet fuel or wood chips and other wood heaters equipped with a fuel feed system, the fuel feed rate, auger motor design and power rating, and the angle of the auger to the firebox; and
(xi) Forced-air combustion system: For wood heaters so equipped, the location and horsepower of blower motors and the fan blade size.
(3) Any change in the materials used for the following components is presumed to affect particulate matter emissions and efficiency:
(i) Refractory/insulation; or
(ii) Door and catalyst bypass gaskets.
(4) A change in the make, model or composition of a catalyst is presumed to affect particulate matter and carbon monoxide emissions and efficiency, unless the change has been requested by the heater manufacturer and has been approved in advance by the Administrator, based on test data that demonstrate that the replacement catalyst is equivalent to or better than the original catalyst in terms of particulate matter emission reduction.
(l) Criteria for revocation of certification. (1) The Administrator may revoke certification if it is determined that the wood heaters being manufactured or sold in that model line do not comply with the requirements of this subpart. Such a determination will be based on all available evidence, including but not limited to:
(1) The Administrator may revoke certification if it is determined that the wood heaters being manufactured or sold in that model line do not comply with the requirements of this subpart. Such a determination will be based on all available evidence, including but not limited to:
(i) Test data from a retesting of the original unit on which the certification test was conducted or a unit that is similar in all material respects that would affect emissions;
(ii) A finding that the certification test was not valid. The finding will be based on problems or irregularities with the certification test or its documentation, but may be supplemented by other information;
(iii) A finding that the labeling of the wood heater model line, the owner's manual or the associated marketing information does not comply with the requirements of Sec. 60.536;
(iv) Failure by the manufacturer to comply with reporting and recordkeeping requirements under Sec. 60.537;
(v) Physical examination showing that a significant percentage (as defined in the quality assurance plan approved pursuant to paragraph (m) of this section, but no larger than 1 percent) of production units inspected is not similar in all material respects that would affect emissions to the representative affected wood heater submitted for certification testing;
(vi) Failure of the manufacturer to conduct a quality assurance program in conformity with paragraph (m) of this section; or
(vii) Failure of the approved laboratory to test the wood heater using the methods specified in Sec. 60.534.
(2) Revocation of certification under this paragraph (l) will not take effect until the manufacturer concerned has been given written notice by the Administrator setting forth the basis for the proposed determination and an opportunity to request a hearing under Sec. 60.539.
(m) Quality assurance program. On or after May 16, 2016, for each certified model line, the manufacturer must conduct a quality assurance program that satisfies the requirements of paragraphs (m)(1) through (5) of this section. The quality assurance program requirements of this paragraph (m) supersede the quality assurance plan requirements previously specified in Sec. 60.533(o) that was in effect prior to May 15, 2015. The manufacturer of a model line with a compliance certification under paragraph (h)(1) of this section must conduct a quality assurance program that satisfies the requirements of this paragraph (m) by May 16, 2016.
(1) The manufacturer must prepare and operate according to a quality assurance plan for each certified model line that includes specific inspection and testing requirements for ensuring that all units within a model line are similar in all material respects that would affect emissions to the wood heater submitted for certification testing and meet the emissions standards in Sec. 60.532.
(2) The quality assurance plan must be approved by the third-party certifier as part of the certification of conformity process specified in paragraph (f) of this section.
(3) The quality assurance plan must include regular (at least annual) unannounced audits by the third-party certifier under ISO-IEC Standard 17065 to ensure that the manufacturer's quality assurance plan is being implemented.
(4) The quality assurance plan must include a report for each audit under ISO-IEC Standard 17065 that fully documents the results of the audit. The third-party certifier must be authorized and required to submit all such reports to the Administrator and the manufacturer within 30 days of the audit. The audit report must identify deviations from the manufacturer's quality assurance plan and specify the corrective actions that need to be taken to address each identified deficiency.
(5) Within 30 days after receiving each audit report, the manufacturer must report to the third-party certifier and to the Administrator its corrective actions and responses to any deficiencies identified in the audit report. No such report is required if an audit report did not identify any deficiencies.
(n) EPA compliance audit testing. (1)(i) The Administrator may select by written notice wood heaters or model lines for compliance audit testing to determine compliance with the emission standards in Sec. 60.532.
(1)(i) The Administrator may select by written notice wood heaters or model lines for compliance audit testing to determine compliance with the emission standards in Sec. 60.532.
(i) The Administrator may select by written notice wood heaters or model lines for compliance audit testing to determine compliance with the emission standards in Sec. 60.532.
(ii) The Administrator will transmit a written notification of the selected wood heaters or model line(s) to the manufacturer, which will include the name and address of the laboratory selected to perform the audit test and the model name and serial number of the wood heater(s) or model line(s) selected to undergo audit testing.
(2)(i) The Administrator may test, or direct the manufacturer to have tested, a wood heater or a wood heater from the model line(s) selected under paragraph (n)(1)(i) of this section in a laboratory approved under Sec. 60.535. The Administrator may select any approved test laboratory or federal laboratory for this audit testing.
(i) The Administrator may test, or direct the manufacturer to have tested, a wood heater or a wood heater from the model line(s) selected under paragraph (n)(1)(i) of this section in a laboratory approved under Sec. 60.535. The Administrator may select any approved test laboratory or federal laboratory for this audit testing.
(ii) The expense of the compliance audit test is the responsibility of the wood heater manufacturer.
(iii) The test must be conducted using the same test method used to obtain certification. If the certification test consisted of more than one particulate matter sampling test method, the Administrator may direct the manufacturer and test laboratory as to which of these methods to use for the purpose of audit testing. The Administrator will notify the manufacturer at least 30 days prior to any test under this paragraph, and allow the manufacturer and/or his authorized representatives to observe the test.
(3) Revocation of certification. (i) If emissions from a wood heater tested under paragraph (n)(2) of this section exceed the applicable emission standard by more than 50 percent using the same test method used to obtain certification, the Administrator will notify the manufacturer that certification for that model line is suspended effective 72 hours from the receipt of the notice, unless the suspension notice is withdrawn by the Administrator. The suspension will remain in effect until withdrawn by the Administrator, or the date 30 days from its effective date if a revocation notice under paragraph (n)(3)(ii) of this section is not issued within that period, or the date of final agency action on revocation, whichever occurs earliest.
(i) If emissions from a wood heater tested under paragraph (n)(2) of this section exceed the applicable emission standard by more than 50 percent using the same test method used to obtain certification, the Administrator will notify the manufacturer that certification for that model line is suspended effective 72 hours from the receipt of the notice, unless the suspension notice is withdrawn by the Administrator. The suspension will remain in effect until withdrawn by the Administrator, or the date 30 days from its effective date if a revocation notice under paragraph (n)(3)(ii) of this section is not issued within that period, or the date of final agency action on revocation, whichever occurs earliest.
(ii)(A) If emissions from a wood heater tested under paragraph (n)(2) of this section exceed the applicable emission limit, the Administrator will notify the manufacturer that certification is revoked for that model line.
(A) If emissions from a wood heater tested under paragraph (n)(2) of this section exceed the applicable emission limit, the Administrator will notify the manufacturer that certification is revoked for that model line.
(B) A revocation notice under paragraph (n)(3)(ii)(A) of this section will become final and effective 60 days after the date of written notification to the manufacturer, unless it is withdrawn, a hearing is requested under Sec. 60.539(a)(2), or the deadline for requesting a hearing is extended.
(C) The Administrator may extend the deadline for requesting a hearing for up to 60 days for good cause.
(D) A manufacturer may extend the deadline for requesting a hearing for up to 6 months, by agreeing to a voluntary suspension of certification.
(iii) Any notification under paragraph (n)(3)(i) or (n)(3)(ii) of this section will include a copy of a preliminary test report from the approved test laboratory or federal test laboratory. The test laboratory must provide a preliminary test report to the Administrator within 14 days of the completion of testing, if a wood heater exceeds the applicable emission limit in Sec. 60.532. The test laboratory must provide the Administrator and the manufacturer, within 30 days of the completion of testing, all documentation pertaining to the test, including the complete test report and raw data sheets, laboratory technician notes, and test results for all test runs.
(iv) Upon receiving notification of a test failure under paragraph (n)(3)(ii) of this section, the manufacturer may request that up to four additional wood heaters from the same model line be tested at the manufacturer's expense, at the test laboratory that performed the emissions test for the Administrator.
(v) Whether or not the manufacturer proceeds under paragraph (n)(3)(iv) of this section, the manufacturer may submit any relevant information to the Administrator, including any other test data generated pursuant to this subpart. The manufacturer must bear the expense of any additional testing.
(vi) The Administrator will withdraw any notice issued under paragraph (n)(3)(ii) of this section if tests under paragraph (n)(3)(iv) of this section show either--
(A) That exactly four additional wood heaters were tested for the manufacturer and all four met the applicable emission limits; or
(B) That exactly two additional wood heaters were tested for the manufacturer and each of them met the applicable emission limits and the average emissions of all three tested heaters (the original audit heater and the two additional heaters) met the applicable emission limits.
(vii) If the Administrator withdraws a notice pursuant to paragraph (n)(3)(vi) of this section, the Administrator will revise the certification values for the model line based on the test data and other relevant information. The manufacturer must then revise the model line's labels and marketing information accordingly.
(viii) The Administrator may withdraw any proposed revocation, if the Administrator finds that an audit test failure has been rebutted by information submitted by the manufacturer under paragraph (n)(3)(iv) of this section and/or (n)(3)(v) of this section or by any other relevant information available to the Administrator.