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Facility DEC ID: 6302200014 PERMIT Under the Environmental Conservation Law (ECL) IDENTIFICATION INFORMATION Permit Type: Air Title V Facility Permit ID: 6-3022-00014/00031 Effective Date: 04/19/2011 Expiration Date: 04/18/2016 Permit Issued To:TYCO HEALTHCARE GROUP LP 15 HAMPSHIRE ST MANSFIELD, MA 02048 Contact: DAVID KELLEY 130 SOUTH MAIN STREET PO BOX 318 ORISKANY FALLS, NY 13425 (315) 821-7233 Facility: TYCO HEALTHCARE KENDALL 130 S MAIN ST|DBA / COVIDIEN ORISKANY FALLS, NY 13425 Contact: DAVID KELLEY 130 SOUTH MAIN STREET PO BOX 318 ORISKANY FALLS, NY 13425 (315) 821-7233 Description: By acceptance of this permit, the permittee agrees that the permit is contingent upon strict compliance with the ECL, all applicable regulations, the General Conditions specified and any Special Conditions included as part of this permit. Permit Administrator: Authorized Signature: PATRICK M CLEAREY NYSDEC - REG 6 207 GENESEE ST UTICA, NY 13501 _________________________________ DEC Permit Conditions Renewal 2/FINAL Date: ___ / ___ / _____ Page 1 Facility DEC ID: 6302200014 Notification of Other State Permittee Obligations Item A: Permittee Accepts Legal Responsibility and Agrees to Indemnification The permittee expressly agrees to indemnify and hold harmless the Department of Environmental Conservation of the State of New York, its representatives, employees and agents ("DEC") for all claims, suits, actions, and damages, to the extent attributable to the permittee's acts or omissions in connection with the compliance permittee's undertaking of activities in connection with, or operation and maintenance of, the facility or facilities authorized by the permit whether in compliance or not in any compliance with the terms and conditions of the permit. This indemnification does not extend to any claims, suits, actions, or damages to the extent attributable to DEC's own negligent or intentional acts or omissions, or to any claims, suits, or actions naming the DEC and arising under article 78 of the New York Civil Practice Laws and Rules or any citizen suit or civil rights provision under federal or state laws. Item B: Permittee's Contractors to Comply with Permit The permittee is responsible for informing its independent contractors, employees, agents and assigns of their responsibility to comply with this permit, including all special conditions while acting as the permittee's agent with respect to the permitted activities, and such persons shall be subject to the same sanctions for violations of the Environmental Conservation Law as those prescribed for the permittee. Item C: Permittee Responsible for Obtaining Other Required Permits The permittee is responsible for obtaining any other permits, approvals, lands, easements and rights-of-way that may be required to carry out the activities that are authorized by this permit. Item D: No Right to Trespass or Interfere with Riparian Rights This permit does not convey to the permittee any right to trespass upon the lands or interfere with the riparian rights of others in order to perform the permitted work nor does it authorize the impairment of any rights, title, or interest in real or personal property held or vested in a person not a party to the permit. DEC Permit Conditions Renewal 2/FINAL Page 2 Facility DEC ID: 6302200014 LIST OF CONDITIONS DEC GENERAL CONDITIONS General Provisions Facility Inspection by the Department Relationship of this Permit to Other Department Orders and Determinations Applications for permit renewals, modifications and transfers Permit modifications, suspensions or revocations by the Department Facility Level Submission of application for permit modification or renewal-REGION 6 SUBOFFICE - UTICA DEC Permit Conditions Renewal 2/FINAL Page 3 Facility DEC ID: 6302200014 DEC GENERAL CONDITIONS **** General Provisions **** For the purpose of your Title V permit, the following section contains state-only enforceable terms and conditions. GENERAL CONDITIONS - Apply to ALL Authorized Permits. Condition 1: Facility Inspection by the Department Applicable State Requirement: ECL 19-0305 Item 1.1: The permitted site or facility, including relevant records, is subject to inspection at reasonable hours and intervals by an authorized representative of the Department of Environmental Conservation (the Department) to determine whether the permittee is complying with this permit and the ECL. Such representative may order the work suspended pursuant to ECL 71-0301 and SAPA 401(3). Item 1.2: The permittee shall provide a person to accompany the Department's representative during an inspection to the permit area when requested by the Department. Item 1.3: A copy of this permit, including all referenced maps, drawings and special conditions, must be available for inspection by the Department at all times at the project site or facility. Failure to produce a copy of the permit upon request by a Department representative is a violation of this permit. Condition 2: Relationship of this Permit to Other Department Orders and Determinations Applicable State Requirement: ECL 3-0301 (2) (m) Item 2.1: Unless expressly provided for by the Department, issuance of this permit does not modify, supersede or rescind any order or determination previously issued by the Department or any of the terms, conditions or requirements contained in such order or determination. Condition 3: Applications for permit renewals, modifications and transfers Applicable State Requirement: 6 NYCRR 621.11 Item 3.1: The permittee must submit a separate written application to the Department for renewal, modification or transfer of this permit. Such application must include any forms or supplemental information the Department requires. Any renewal, modification or transfer granted by the Department must be in writing. Item 3.2: The permittee must submit a renewal application at least 180 days before expiration of permits for Title V Facility Permits, or at least 30 days before expiration of permits for State Facility Permits. Item 3.3: Permits are transferrable with the approval of the department unless specifically prohibited by the statute, regulation or another permit condition. Applications for permit transfer should be submitted prior to actual transfer of ownership. DEC Permit Conditions Renewal 2/FINAL Page 4 Facility DEC ID: 6302200014 Condition 4: Permit modifications, suspensions or revocations by the Department Applicable State Requirement: 6 NYCRR 621.13 Item 4.1: The Department reserves the right to modify, suspend, or revoke this permit in accordance with 6NYCRR Part 621. The grounds for modification, suspension or revocation include: a) materially false or inaccurate statements in the permit application or supporting papers; b) failure by the permittee to comply with any terms or conditions of the permit; c) exceeding the scope of the project as described in the permit application; d) newly discovered material information or a material change in environmental conditions, relevant technology or applicable law or regulations since the issuance of the existing permit; e) noncompliance with previously issued permit conditions, orders of the commissioner, any provisions of the Environmental Conservation Law or regulations of the Department related to the permitted activity. **** Facility Level **** Condition 5: Submission of application for permit modification or renewal-REGION 6 SUBOFFICE - UTICA Applicable State Requirement: 6 NYCRR 621.6 (a) Item 5.1: Submission of applications for permit modification or renewal are to be submitted to: NYSDEC Regional Permit Administrator Region 6 Sub-office Division of Environmental Permits State Office Building, 207 Genesee Street Utica, NY 13501-2885 (315) 793-2555 DEC Permit Conditions Renewal 2/FINAL Page 5 Permit ID: 6-3022-00014/00031 Facility DEC ID: 6302200014 Permit Under the Environmental Conservation Law (ECL) ARTICLE 19: AIR POLLUTION CONTROL - TITLE V PERMIT IDENTIFICATION INFORMATION Permit Issued To:TYCO HEALTHCARE GROUP LP 15 HAMPSHIRE ST MANSFIELD, MA 02048 Facility: TYCO HEALTHCARE KENDALL 130 S MAIN ST|DBA / COVIDIEN ORISKANY FALLS, NY 13425 Authorized Activity By Standard Industrial Classification Code: 2299 - TEXTILE GOODS, NEC 3841 - SURGICAL & MEDICAL INSTRUMENTS 3842 - SURGICAL APPLIANCES & SUPPLIES Permit Effective Date: 04/19/2011 Renewal 2 Permit Expiration Date: 04/18/2016 Air Pollution Control Permit Conditions FINAL Page 1 Permit ID: 6-3022-00014/00031 Facility DEC ID: 6302200014 LIST OF CONDITIONS FEDERALLY ENFORCEABLE CONDITIONS Facility Level 1 6 NYCRR 200.6: Acceptable Ambient Air Quality 2 6 NYCRR 201-6.5 (a) (7): Fees 3 6 NYCRR 201-6.5 (c): Recordkeeping and reporting of compliance monitoring 4 6 NYCRR 201-6.5 (c) (2): Monitoring, Related Recordkeeping, and Reporting Requirements. 5 6 NYCRR 201-6.5 (c) (3) (ii): Compliance Certification 6 6 NYCRR 201-6.5 (e): Compliance Certification 7 6 NYCRR 202-2.1: Compliance Certification 8 6 NYCRR 202-2.5: Recordkeeping requirements 9 6 NYCRR 215.2: Open Fires - Prohibitions 10 6 NYCRR 200.7: Maintenance of Equipment 11 6 NYCRR 201-1.7: Recycling and Salvage 12 6 NYCRR 201-1.8: Prohibition of Reintroduction of Collected Contaminants to the air 13 6 NYCRR 201-3.2 (a): Exempt Sources - Proof of Eligibility 14 6 NYCRR 201-3.3 (a): Trivial Sources - Proof of Eligibility 15 6 NYCRR 201-6.5 (a) (4): Standard Requirement - Provide Information 16 6 NYCRR 201-6.5 (a) (8): General Condition - Right to Inspect 17 6 NYCRR 201-6.5 (d) (5): Standard Requirements - Progress Reports 18 6 NYCRR 201-6.5 (f) (6): Off Permit Changes 19 6 NYCRR 202-1.1: Required Emissions Tests 20 6 NYCRR 211.3: Visible Emissions Limited 21 40 CFR Part 68: Accidental release provisions. 22 40CFR 82, Subpart F: Recycling and Emissions Reduction 23 6 NYCRR 201-3.1 (a): Exempt and Trivial Activities Applicability 24 6 NYCRR Subpart 201-6: Emission Unit Definition 25 6 NYCRR 201-6.5 (f): Compliance Certification 26 6 NYCRR 201-6.5 (g): Non Applicable requirements 27 6 NYCRR 201-7.2: Facility Permissible Emissions *28 6 NYCRR 201-7.2: Capping Monitoring Condition *29 6 NYCRR 201-7.2: Capping Monitoring Condition 30 6 NYCRR 202-1.2: Notification 31 6 NYCRR 202-1.3: Acceptable procedures 32 6 NYCRR 202-1.3: Acceptable procedures - Stack test report submittal 33 6 NYCRR 202-1.3: Alternate test methods 34 6 NYCRR 212.6 (a): Compliance Certification 35 6 NYCRR 225-1.8 (a): Compliance Certification 36 6 NYCRR 225-1.8 (d): Sampling, compositing, and analysis of fuel samples 37 6 NYCRR Part 226: Compliance Certification 38 6 NYCRR 227-1.3 (a): Compliance Certification 39 6 NYCRR 227-1.6 (b): Corrective action. 40 6 NYCRR 227-1.6 (c): Corrective action. 41 6 NYCRR 227-1.6 (d): Corrective action. 42 6 NYCRR 228-1.1 (d): Will remain subject 43 6 NYCRR 228-1.2 (b) (35): Compliance Certification Renewal 2 Air Pollution Control Permit Conditions FINAL Page 2 Permit ID: 6-3022-00014/00031 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 Facility DEC ID: 6302200014 6 NYCRR 228-1.3 (c): Solids as applied 6 NYCRR 228-1.4: Compliance Certification 6 NYCRR 228-1.5 (a): Compliance Certification 6 NYCRR 228-1.5 (c): Compliance Certification 6 NYCRR 228-1.5 (e) (2): Demonstration of efficiency other than VOC/solvent recovery 6 NYCRR 228-1.5 (j): Compliance Certification 6 NYCRR 228-1.5 (k): Compliance Certification 6 NYCRR 228-1.10: Compliance Certification 40CFR 60.4, NSPS Subpart A: EPA Region 2 address. 40CFR 60.14, NSPS Subpart A: Modifications. 40CFR 60.445(h), NSPS Subpart RR: Compliance Certification 40CFR 63.4, Subpart A: Prohibitions 40CFR 63.6(e)(1)(i), Subpart A: Operation and Maintenance Requirements 40CFR 63.9, Subpart A: 40 CFR 63.9 (b)(4) Construct/Reconstruct Notification 40CFR 63.10, Subpart A: § 63.10(b) General Recordkeeping Requirements 40CFR 63.10, Subpart A: §63.10(d) General Reporting Requirements 40CFR 63.1306, Subpart III: Reporting Requirements - All Affected Sources 40CFR 63.1307(b), Subpart III: Compliance Certification 40 CFR 64.9: Compliance Certification Emission Unit Level 6 NYCRR Subpart 201-6: Emission Point Definition By Emission Unit 6 NYCRR Subpart 201-6: Process Definition By Emission Unit EU=U-00001 65 6 NYCRR 227-1.3 (a): Compliance Certification 66 6 NYCRR 227.2 (b) (1): Compliance Certification EU=U-00001,Proc=01A,ES=S0001 67 6 NYCRR 225-1.2 (a) (2): Compliance Certification 68 6 NYCRR 212.4 (c): Compliance Certification 69 40CFR 60.440(b), NSPS Subpart RR: Compliance Certification 70 71 72 73 74 75 76 77 78 EU=U-00002,Proc=002 6 NYCRR 228-1.5 (b): Compliance Certification 40CFR 60.7(a)(4), NSPS Subpart A: Compliance Certification 40CFR 60.7(b), NSPS Subpart A: Recordkeeping requirements. 40CFR 60.7(f), NSPS Subpart A: Facility files for subject sources. 40CFR 60.9, NSPS Subpart A: Availability of information. 40CFR 60.11, NSPS Subpart A: Opacity standard compliance testing. 40CFR 60.12, NSPS Subpart A: Circumvention. 40CFR 60.13, NSPS Subpart A: Monitoring requirements. 40CFR 60.15, NSPS Subpart A: Reconstruction. EU=U-00002,Proc=002,ES=C0002 79 6 NYCRR 228-1.3 (c): Compliance Certification 80 6 NYCRR 228-1.5 (f): Compliance Certification EU=U-00002,Proc=002,ES=C0003 81 6 NYCRR 228-1.5 (g) (1): Compliance Certification Renewal 2 Air Pollution Control Permit Conditions FINAL Page 3 Permit ID: 6-3022-00014/00031 Facility DEC ID: 6302200014 EU=U-00002,Proc=002,ES=S0002 82 40CFR 60.445(d), NSPS Subpart RR: Compliance Certification EU=U-00002,Proc=004 83 6 NYCRR 228-1.5 (b): Compliance Certification 84 6 NYCRR 228-1.7: Compliance Certification EU=U-00008 85 40CFR 63.6(b)(2), Subpart A: Compliance dates for new and reconstructed sources 86 40CFR 63.1293, Subpart III: Slabstock Production 87 40CFR 63.1294, Subpart III: Limited Standards for Slabstock Foam Production 88 40CFR 63.1306(e), Subpart III: Compliance Certification 89 40CFR 63.1306(f), Subpart III: Compliance Certification 90 40CFR 63.1307(b), Subpart III: Compliance Certification 91 40CFR 63.1307(e), Subpart III: Compliance Certification 92 93 94 95 96 97 STATE ONLY ENFORCEABLE CONDITIONS Facility Level ECL 19-0301: Contaminant List 6 NYCRR 201-1.4: Unavoidable noncompliance and violations 6 NYCRR 211.2: Air pollution prohibited 6 NYCRR 211.2: Compliance Demonstration 6 NYCRR 212.4 (a): Emissions from new emission sources and/or modifications 6 NYCRR 221.2: Asbestos containing surface coatings prohibited NOTE: * preceding the condition number indicates capping. Renewal 2 Air Pollution Control Permit Conditions FINAL Page 4 Permit ID: 6-3022-00014/00031 Facility DEC ID: 6302200014 FEDERALLY ENFORCEABLE CONDITIONS **** Facility Level **** NOTIFICATION OF GENERAL PERMITTEE OBLIGATIONS The items listed below are not subject to the annual compliance certification requirements under Title V. Permittees may also have other obligations under regulations of general applicability. Item A: Emergency Defense - 6 NYCRR 201-1.5 An emergency constitutes an affirmative defense to an action brought for noncompliance with emissions limitations or permit conditions for all facilities in New York State. (a) The affirmative defense of emergency shall be demonstrated through properly signed, contemporaneous operating logs, or other relevant evidence that: (1) An emergency occurred and that the facility owner and/or operator can identify the cause(s) of the emergency; (2) The equipment at the permitted facility causing the emergency was at the time being properly operated; (3) During the period of the emergency the facility owner and/or operator took all reasonable steps to minimize levels of emissions that exceeded the emission standards, or other requirements in the permit; and (4) The facility owner and/or operator notified the Department within two working days after the event occurred. This notice must contain a description of the emergency, any steps taken to mitigate emissions, and corrective actions taken. (b) In any enforcement proceeding, the facility owner and/or operator seeking to establish the occurrence of an emergency has the burden of proof. (c) This provision is in addition to any emergency or upset provision contained in any applicable requirement. Item B: Renewal 2 Public Access to Recordkeeping for Title V Facilities - 6 NYCRR 201-1.10 (b) The Department will make available to the public any permit application, compliance plan, permit, and monitoring and compliance certification report pursuant to Section 503(e) of the Act, except for information entitled to confidential treatment pursuant to 6 NYCRR Part 616 Public Access to records and Section 114(c) of the Act. Air Pollution Control Permit Conditions FINAL Page 5 Permit ID: 6-3022-00014/00031 Facility DEC ID: 6302200014 Item C: Timely Application for the Renewal of Title V Permits - 6 NYCRR 201-6.3 (a) (4) Owners and/or operators of facilities having an issued Title V permit shall submit a complete application at least 180 days, but not more than eighteen months, prior to the date of permit expiration for permit renewal purposes. Item D: Certification by a Responsible Official - 6 NYCRR 201-6.3 (d) (12) Any application, form, report or compliance certification required to be submitted pursuant to the federally enforceable portions of this permit shall contain a certification of truth, accuracy and completeness by a responsible official. This certification shall state that based on information and belief formed after reasonable inquiry, the statements and information in the document are true, accurate, and complete. Item E: Requirement to Comply With All Conditions - 6 NYCRR 201-6.5 (a) (2) The permittee must comply with all conditions of the Title V facility permit. Any permit non-compliance constitutes a violation of the Act and is grounds for enforcement action; for permit termination, revocation and reissuance, or modification; or for denial of a permit renewal application. Item F: Permit Revocation, Modification, Reopening, Reissuance or Termination, and Associated Information Submission Requirements - 6 NYCRR 201-6.5 (a) (3) This permit may be modified, revoked, reopened and reissued, or terminated for cause. The filing of a request by the permittee for a permit modification, revocation and reissuance, or termination, or of a notification of planned changes or anticipated noncompliance does not stay any permit condition. Item G: Cessation or Reduction of Permitted Activity Not a Defense - 6 NYCRR 201-6.5 (a) (5) It shall not be a defense for a permittee in an enforcement action to claim that a cessation or reduction in the permitted activity would have been necessary in order to maintain compliance with the conditions of this permit. Item H: Property Rights - 6 NYCRR 201-6.5 (a) (6) This permit does not convey any property rights of any sort or any exclusive privilege. Renewal 2 Air Pollution Control Permit Conditions FINAL Page 6 Permit ID: 6-3022-00014/00031 Item I: Facility DEC ID: 6302200014 Severability - 6 NYCRR 201-6.5 (a) (9) If any provisions, parts or conditions of this permit are found to be invalid or are the subject of a challenge, the remainder of this permit shall continue to be valid. Item J: Permit Shield - 6 NYCRR 201-6.5 (g) All permittees granted a Title V facility permit shall be covered under the protection of a permit shield, except as provided under 6 NYCRR Subpart 201-6. Compliance with the conditions of the permit shall be deemed compliance with any applicable requirements as of the date of permit issuance, provided that such applicable requirements are included and are specifically identified in the permit, or the Department, in acting on the permit application or revision, determines in writing that other requirements specifically identified are not applicable to the major stationary source, and the permit includes the determination or a concise summary thereof. Nothing herein shall preclude the Department from revising or revoking the permit pursuant to 6 NYCRR Part 621 or from exercising its summary abatement authority. Nothing in this permit shall alter or affect the following: i. The ability of the Department to seek to bring suit on behalf of the State of New York, or the Administrator to seek to bring suit on behalf of the United States, to immediately restrain any person causing or contributing to pollution presenting an imminent and substantial endangerment to public health, welfare or the environment to stop the emission of air pollutants causing or contributing to such pollution; ii. The liability of a permittee of the Title V facility for any violation of applicable requirements prior to or at the time of permit issuance; iii. The applicable requirements of Title IV of the Act; iv. The ability of the Department or the Administrator to obtain information from the permittee concerning the ability to enter, inspect and monitor the facility. Item K: Reopening for Cause - 6 NYCRR 201-6.5 (i) This Title V permit shall be reopened and revised under any of the following circumstances: i. If additional applicable requirements under the Act become applicable where this permit's remaining term is Renewal 2 Air Pollution Control Permit Conditions FINAL Page 7 Permit ID: 6-3022-00014/00031 Facility DEC ID: 6302200014 three or more years, a reopening shall be completed not later than 18 months after promulgation of the applicable requirement. No such reopening is required if the effective date of the requirement is later than the date on which this permit is due to expire, unless the original permit or any of its terms and conditions has been extended by the Department pursuant to the provisions of Part 201-6.7 and Part 621. ii. The Department or the Administrator determines that the permit contains a material mistake or that inaccurate statements were made in establishing the emissions standards or other terms or conditions of the permit. iii. The Department or the Administrator determines that the Title V permit must be revised or reopened to assure compliance with applicable requirements. iv. If the permitted facility is an "affected source" subject to the requirements of Title IV of the Act, and additional requirements (including excess emissions requirements) become applicable. Upon approval by the Administrator, excess emissions offset plans shall be deemed to be incorporated into the permit. Proceedings to reopen and issue Title V facility permits shall follow the same procedures as apply to initial permit issuance but shall affect only those parts of the permit for which cause to reopen exists. Reopenings shall not be initiated before a notice of such intent is provided to the facility by the Department at least thirty days in advance of the date that the permit is to be reopened, except that the Department may provide a shorter time period in the case of an emergency. Item L: Renewal 2 Permit Exclusion - ECL 19-0305 The issuance of this permit by the Department and the receipt thereof by the Applicant does not and shall not be construed as barring, diminishing, adjudicating or in any way affecting any legal, administrative or equitable rights or claims, actions, suits, causes of action or demands whatsoever that the Department may have against the Applicant for violations based on facts and circumstances alleged to have occurred or existed prior to the effective date of this permit, including, but not limited to, any enforcement action authorized pursuant to the provisions of applicable federal law, the Environmental Conservation Law of the State of New York (ECL) and Chapter III of the Official Compilation of the Codes, Rules and Regulations of the State of New York Air Pollution Control Permit Conditions FINAL Page 8 Permit ID: 6-3022-00014/00031 Facility DEC ID: 6302200014 (NYCRR). The issuance of this permit also shall not in any way affect pending or future enforcement actions under the Clean Air Act brought by the United States or any person. Item M: Federally Enforceable Requirements - 40 CFR 70.6 (b) All terms and conditions in this permit required by the Act or any applicable requirement, including any provisions designed to limit a facility's potential to emit, are enforceable by the Administrator and citizens under the Act. The Department has, in this permit, specifically designated any terms and conditions that are not required under the Act or under any of its applicable requirements as being enforceable under only state regulations. MANDATORY FEDERALLY ENFORCEABLE PERMIT CONDITIONS SUBJECT TO ANNUAL CERTIFICATIONS AT ALL TIMES The following federally enforceable permit conditions are mandatory for all Title V permits and are subject to annual compliance certification requirements at all times. Condition 1: Acceptable Ambient Air Quality Effective between the dates of 04/19/2011 and 04/18/2016 Applicable Federal Requirement:6 NYCRR 200.6 Item 1.1: Notwithstanding the provisions of 6 NYCRR Chapter III, Subchapter A, no person shall allow or permit any air contamination source to emit air contaminants in quantities which alone or in combination with emissions from other air contamination sources would contravene any applicable ambient air quality standard and/or cause air pollution. In such cases where contravention occurs or may occur, the Commissioner shall specify the degree and/or method of emission control required. Condition 2: Fees Effective between the dates of 04/19/2011 and 04/18/2016 Applicable Federal Requirement:6 NYCRR 201-6.5 (a) (7) Item 2.1: The owner and/or operator of a stationary source shall pay fees to the Department consistent with the fee schedule authorized by ECL 72-0303. Condition 3: Recordkeeping and reporting of compliance monitoring Effective between the dates of 04/19/2011 and 04/18/2016 Applicable Federal Requirement:6 NYCRR 201-6.5 (c) Item 3.1: Renewal 2 Air Pollution Control Permit Conditions FINAL Page 9 Permit ID: 6-3022-00014/00031 Facility DEC ID: 6302200014 The following information must be included in any required compliance monitoring records and reports: (i) The date, place, and time of sampling or measurements; (ii) The date(s) analyses were performed; (iii)The company or entity that performed the analyses; (iv) The analytical techniques or methods used including quality assurance and quality control procedures if required; (v) The results of such analyses including quality assurance data where required; and (vi) The operating conditions as existing at the time of sampling or measurement. Any deviation from permit requirements must be clearly identified in all records and reports. Reports must be certified by a responsible official, consistent with Section 201-6.3 of this Part 201. Condition 4: Monitoring, Related Recordkeeping, and Reporting Requirements. Effective between the dates of 04/19/2011 and 04/18/2016 Applicable Federal Requirement:6 NYCRR 201-6.5 (c) (2) Item 4.1: Compliance monitoring and recordkeeping shall be conducted according to the terms and conditions contained in this permit and shall follow all quality assurance requirements found in applicable regulations. Records of all monitoring data and support information must be retained for a period of at least 5 years from the date of the monitoring, sampling, measurement, report, or application. Support information includes all calibration and maintenance records and all original strip-chart recordings for continuous monitoring instrumentation, and copies of all reports required by the permit. Condition 5: Compliance Certification Effective between the dates of 04/19/2011 and 04/18/2016 Applicable Federal Requirement:6 NYCRR 201-6.5 (c) (3) (ii) Item 5.1: The Compliance Certification activity will be performed for the Facility. Item 5.2: Compliance Certification shall include the following monitoring: Monitoring Type: RECORD KEEPING/MAINTENANCE PROCEDURES Monitoring Description: To meet the requirements of this facility permit with respect to reporting, the permittee must: Submit reports of any required monitoring at a minimum Renewal 2 Air Pollution Control Permit Conditions FINAL Page 10 Permit ID: 6-3022-00014/00031 Facility DEC ID: 6302200014 frequency of every 6 months, based on a calendar year reporting schedule. These reports shall be submitted to the Department within 30 days after the end of a reporting period. All instances of deviations from permit requirements must be clearly identified in such reports. All required reports must be certified by the responsible official for this facility. Notify the Department and report permit deviations and incidences of noncompliance stating the probable cause of such deviations, and any corrective actions or preventive measures taken. Where the underlying applicable requirement contains a definition of prompt or otherwise specifies a time frame for reporting deviations, that definition or time frame shall govern. Where the underlying applicable requirement fails to address the time frame for reporting deviations, reports of deviations shall be submitted to the permitting authority based on the following schedule: (1) For emissions of a hazardous air pollutant or a toxic air pollutant (as identified in an applicable regulation) that continue for more than an hour in excess of permit requirements, the report must be made within 24 hours of the occurrence. (2) For emissions of any regulated air pollutant, excluding those listed in paragraph (1) of this section, that continue for more than two hours in excess of permit requirements, the report must be made within 48 hours. (3) For all other deviations from permit requirements, the report shall be contained in the 6 month monitoring report required above. (4) This permit may contain a more stringent reporting requirement than required by paragraphs (1), (2) or (3) above. If more stringent reporting requirements have been placed in this permit or exist in applicable requirements that apply to this facility, the more stringent reporting requirement shall apply. If any of the above conditions are met, the source must notify the permitting authority by telephone during normal business hours at the Regional Office of jurisdiction for this permit, attention Regional Air Pollution Control Engineer (RAPCE) according to the timetable listed in paragraphs (1) through (4) of this section. For deviations and incidences that must be reported outside of normal business hours, on weekends, or holidays, the DEC Spill Hotline phone number at 1-800-457-7362 shall be Renewal 2 Air Pollution Control Permit Conditions FINAL Page 11 Permit ID: 6-3022-00014/00031 Facility DEC ID: 6302200014 used. A written notice, certified by a responsible official consistent with 6 NYCRR Part 201-6.3(d)(12), must be submitted within 10 working days of an occurrence for deviations reported under (1) and (2). All deviations reported under paragraph (1) through (4) of this section must also be identified in the 6 month monitoring report required above. If the permittee seeks to have a violation excused as provided in 201-1.4, the permittee shall report such violations as required under 201-1.4(b). However, in no case may reports of any deviation be on a less frequent basis than those described in paragraphs (1) though (4) above. In order to have a violation of a federal regulation (such as a new source performance standard or national emissions standard for hazardous air pollutants) excused, the specific federal regulation must provide for an affirmative defense during start-up, shutdowns, malfunctions or upsets. In the case of any condition contained in this permit with a reporting requirement of "Upon request by regulatory agency" the permittee shall include in the semiannual report, a statement for each such condition that the monitoring or recordkeeping was performed as required or requested and a listing of all instances of deviations from these requirements. In the case of any emission testing performed during the previous six month reporting period, either due to a request by the Department, EPA, or a regulatory requirement, the permittee shall include in the semiannual report a summary of the testing results and shall indicate whether or not the Department or EPA has approved the results. All semiannual reports shall be submitted to the Administrator (or his or her representative) as well as two copies to the Department (one copy to the regional air pollution control engineer (RAPCE) in the regional office and one copy to the Bureau of Compliance Monitoring and Enforcement (BCME) in the DEC central office). Mailing addresses for the above referenced persons are contained in the monitoring condition for 6 NYCRR Part 201-6.5(e), contained elsewhere in this permit. Reporting Requirements: SEMI-ANNUALLY (CALENDAR) Reports due 30 days after the reporting period. The initial report is due 7/30/2011. Subsequent reports are due every 6 calendar month(s). Condition 6: Renewal 2 Compliance Certification Air Pollution Control Permit Conditions FINAL Page 12 Permit ID: 6-3022-00014/00031 Facility DEC ID: 6302200014 Effective between the dates of 04/19/2011 and 04/18/2016 Applicable Federal Requirement:6 NYCRR 201-6.5 (e) Item 6.1: The Compliance Certification activity will be performed for the Facility. Item 6.2: Compliance Certification shall include the following monitoring: Monitoring Type: RECORD KEEPING/MAINTENANCE PROCEDURES Monitoring Description: Requirements for compliance certifications with terms and conditions contained in this facility permit include the following: i. Compliance certifications shall contain: - the identification of each term or condition of the permit that is the basis of the certification; - the compliance status; - whether compliance was continuous or intermittent; - the method(s) used for determining the compliance status of the facility, currently and over the reporting period consistent with the monitoring and related recordkeeping and reporting requirements of this permit; - such other facts as the Department may require to determine the compliance status of the facility as specified in any special permit terms or conditions; and - such additional requirements as may be specified elsewhere in this permit related to compliance certification. ii. The responsible official must include in the annual certification report all terms and conditions contained in this permit which are identified as being subject to certification, including emission limitations, standards, or work practices. That is, the provisions labeled herein as "Compliance Certification" are not the only provisions of this permit for which an annual certification is required. iii. Compliance certifications shall be submitted annually. Certification reports are due 30 days after the anniversary date of four consecutive calendar quarters. The first report is due 30 days after the calendar quarter that occurs just prior to the permit anniversary date, unless another quarter has been acceptable by the Department. iv. All compliance certifications shall be submitted to the Administrator (or his or her representative) as well Renewal 2 Air Pollution Control Permit Conditions FINAL Page 13 Permit ID: 6-3022-00014/00031 Facility DEC ID: 6302200014 as two copies to the Department (one copy to the regional air pollution control engineer (RAPCE) in the regional office and one copy to the Bureau of Compliance Monitoring and Enforcement (BCME) in the DEC central office). Please send annual compliance certifications to Chief of the Stationary Source Compliance Section, the Region 2 EPA representative for the Administrator, at the following address: USEPA Region 2 Air Compliance Branch 290 Broadway New York, NY 10007-1866 The address for the RAPCE is as follows: State Office Building 317 Washington Street Watertown, NY 13601-3787 The address for the BCME is as follows: NYSDEC Bureau of Compliance Monitoring and Enforcement 625 Broadway Albany, NY 12233-3258 Monitoring Frequency: ANNUALLY Reporting Requirements: ANNUALLY (CALENDAR) Reports due 30 days after the reporting period. The initial report is due 1/30/2012. Subsequent reports are due on the same day each year Condition 7: Compliance Certification Effective between the dates of 04/19/2011 and 04/18/2016 Applicable Federal Requirement:6 NYCRR 202-2.1 Item 7.1: The Compliance Certification activity will be performed for the Facility. Item 7.2: Compliance Certification shall include the following monitoring: Monitoring Type: RECORD KEEPING/MAINTENANCE PROCEDURES Monitoring Description: Emission statements shall be submitted on or before April 15th each year for emissions of the previous calendar year. Monitoring Frequency: ANNUALLY Renewal 2 Air Pollution Control Permit Conditions FINAL Page 14 Permit ID: 6-3022-00014/00031 Facility DEC ID: 6302200014 Reporting Requirements: ANNUALLY (CALENDAR) Reports due by April 15th for previous calendar year Condition 8: Recordkeeping requirements Effective between the dates of 04/19/2011 and 04/18/2016 Applicable Federal Requirement:6 NYCRR 202-2.5 Item 8.1: (a) The following records shall be maintained for at least five years: (1) a copy of each emission statement submitted to the department; and (2) records indicating how the information submitted in the emission statement was determined, including any calculations, data, measurements, and estimates used. (b) These records shall be made available at the facility to the representatives of the department upon request during normal business hours. Condition 9: Open Fires - Prohibitions Effective between the dates of 04/19/2011 and 04/18/2016 Applicable Federal Requirement:6 NYCRR 215.2 Item 9.1: Except as allowed by Title 6 NYCRR Section 215.3, no person shall burn, cause, suffer, allow or permit the burning of any materials in an open fire. Item 9.2 Per Section 215.3, burning in an open fire, provided it is not contrary to other law or regulation, will be allowed as follows: (a) On-site burning in any town with a total population less than 20,000 of downed limbs and branches (including branches with attached leaves or needles) less than six inches in diameter and eight feet in length between May 15th and the following March 15th. For the purposes of this subdivision, the total population of a town shall include the population of any village or portion thereof located within the town. However, this subdivision shall not be construed to allow burning within any village. (b) Barbecue grills, maple sugar arches and similar outdoor cooking devices when actually used for cooking or processing food. (c) Small fires used for cooking and camp fires provided that only charcoal or untreated wood is used as fuel and the fire is not left unattended until extinguished. (d) On-site burning of agricultural wastes as part of a valid agricultural operation on contiguous agricultural lands larger than five acres actively devoted to agricultural or horticultural use, provided such waste is actually grown or generated on those lands and such waste is capable of being fully burned within a 24-hour period. (e) The use of liquid petroleum fueled smudge pots to prevent frost damage to crops. (f) Ceremonial or celebratory bonfires where not otherwise prohibited by law, provided that only untreated wood or other agricultural products are used as fuel and the fire is not left unattended until extinguished. (g) Small fires that are used to dispose of a flag or religious item, and small fires or other smoke producing process where not otherwise prohibited by law that are used in connection with a religious ceremony. Renewal 2 Air Pollution Control Permit Conditions FINAL Page 15 Permit ID: 6-3022-00014/00031 Facility DEC ID: 6302200014 (h) Burning on an emergency basis of explosive or other dangerous or contraband materials by police or other public safety organization. (i) Prescribed burns performed according to Part 194 of this Title. (j) Fire training, including firefighting, fire rescue, and fire/arson investigation training, performed under applicable rules and guidelines of the New York State Department of State's Office of Fire Prevention and Control. For fire training performed on acquired structures, the structures must be emptied and stripped of any material that is toxic, hazardous or likely to emit toxic smoke (such as asbestos, asphalt shingles and vinyl siding or other vinyl products) prior to burning and must be at least 300 feet from other occupied structures. No more than one structure per lot or within a 300 foot radius (whichever is bigger) may be burned in a training exercise. (k) Individual open fires as approved by the Director of the Division of Air Resources as may be required in response to an outbreak of a plant or animal disease upon request by the commissioner of the Department of Agriculture and Markets, or for the destruction of invasive plant and insect species. (l) Individual open fires that are otherwise authorized under the environmental conservation law, or by rule or regulation of the Department. MANDATORY FEDERALLY ENFORCEABLE PERMIT CONDITIONS SUBJECT TO ANNUAL CERTIFICATIONS ONLY IF APPLICABLE The following federally enforceable permit conditions are mandatory for all Title V permits and are subject to annual compliance certification requirements only if effectuated during the reporting period. [NOTE: The corresponding annual compliance certification for those conditions not effectuated during the reporting period shall be specified as "not applicable".] Condition 10: Maintenance of Equipment Effective between the dates of 04/19/2011 and 04/18/2016 Applicable Federal Requirement:6 NYCRR 200.7 Item 10.1: Any person who owns or operates an air contamination source which is equipped with an emission control device shall operate such device and keep it in a satisfactory state of maintenance and repair in accordance with ordinary and necessary practices, standards and procedures, inclusive of manufacturer's specifications, required to operate such device effectively. Condition 11: Recycling and Salvage Effective between the dates of 04/19/2011 and 04/18/2016 Applicable Federal Requirement:6 NYCRR 201-1.7 Item 11.1: Where practical, any person who owns or operates an air contamination source shall recycle or salvage air contaminants collected in an air cleaning device according to the requirements of the ECL. Condition 12: Renewal 2 Prohibition of Reintroduction of Collected Contaminants to Air Pollution Control Permit Conditions FINAL Page 16 Permit ID: 6-3022-00014/00031 Facility DEC ID: 6302200014 the air Effective between the dates of 04/19/2011 and 04/18/2016 Applicable Federal Requirement:6 NYCRR 201-1.8 Item 12.1: No person shall unnecessarily remove, handle or cause to be handled, collected air contaminants from an air cleaning device for recycling, salvage or disposal in a manner that would reintroduce them to the outdoor atmosphere. Condition 13: Exempt Sources - Proof of Eligibility Effective between the dates of 04/19/2011 and 04/18/2016 Applicable Federal Requirement:6 NYCRR 201-3.2 (a) Item 13.1: The owner and/or operator of an emission source or unit that is eligible to be exempt may be required to certify that it operates within the specific criteria described in this Subpart. The owner or operator of any such emission source must maintain all required records on-site for a period of five years and make them available to representatives of the department upon request. Department representatives must be granted access to any facility which contains emission sources or units subject to this Subpart, during normal operating hours, for the purpose of determining compliance with this and any other State and Federal air pollution control requirements, regulations, or law. Condition 14: Trivial Sources - Proof of Eligibility Effective between the dates of 04/19/2011 and 04/18/2016 Applicable Federal Requirement:6 NYCRR 201-3.3 (a) Item 14.1: The owner and/or operator of an emission source or unit that is listed as being trivial in this Part may be required to certify that it operates within the specific criteria described in this Subpart. The owner or operator of any such emission source must maintain all required records on-site for a period of five years and make them available to representatives of the department upon request. Department representatives must be granted access to any facility which contains emission sources or units subject to this Subpart, during normal operating hours, for the purpose of determining compliance with this and any other State and Federal air pollution control requirements, regulations, or law. Condition 15: Standard Requirement - Provide Information Effective between the dates of 04/19/2011 and 04/18/2016 Applicable Federal Requirement:6 NYCRR 201-6.5 (a) (4) Item 15.1: The owner and/or operator shall furnish to the department, within a reasonable time, any information that the department may request in writing to determine whether cause exists for modifying, revoking and reissuing, or terminating the permit or to determine compliance with the permit. Upon request, the permittee shall also furnish to the department copies of records required to be kept by the permit or, for information claimed to be confidential, the permittee may furnish such records directly to the administrator along with a claim of confidentiality, if the Renewal 2 Air Pollution Control Permit Conditions FINAL Page 17 Permit ID: 6-3022-00014/00031 Facility DEC ID: 6302200014 administrator initiated the request for information or otherwise has need of it. Condition 16: General Condition - Right to Inspect Effective between the dates of 04/19/2011 and 04/18/2016 Applicable Federal Requirement:6 NYCRR 201-6.5 (a) (8) Item 16.1: The department or an authorized representative shall be allowed upon presentation of credentials and other documents as may be required by law to: (i) enter upon the permittee's premises where a facility subject to the permitting requirements of this Subpart is located or emissions-related activity is conducted, or where records must be kept under the conditions of the permit; (ii) have access to and copy, at reasonable times, any records that must be kept under the conditions of the permit; (iii) inspect at reasonable times any emission sources, equipment (including monitoring and air pollution control equipment), practices, and operations regulated or required under the permit; and (iv) sample or monitor at reasonable times substances or parameters for the purpose of assuring compliance with the permit or applicable requirements. Condition 17: Standard Requirements - Progress Reports Effective between the dates of 04/19/2011 and 04/18/2016 Applicable Federal Requirement:6 NYCRR 201-6.5 (d) (5) Item 17.1: Progress reports consistent with an applicable schedule of compliance are to be submitted at least semiannually, or at a more frequent period if specified in the applicable requirement or by the department. Such progress reports shall contain the following: (i) dates for achieving the activities, milestones, or compliance required in the schedule of compliance, and dates when such activities, milestones or compliance were achieved; and (ii) an explanation of why any dates in the schedule of compliance were not or will not be met, and any preventive or corrective measures adopted. Condition 18: Off Permit Changes Effective between the dates of 04/19/2011 and 04/18/2016 Applicable Federal Requirement:6 NYCRR 201-6.5 (f) (6) Item 18.1: No permit revision will be required for operating changes that contravene an express permit term, provided that such changes would not violate applicable requirements as defined under this Part or contravene federally enforceable monitoring (including test methods), recordkeeping, reporting, or compliance certification permit terms and conditions. Such changes may be made without requiring a permit revision, if the changes are not modifications under any provision of Renewal 2 Air Pollution Control Permit Conditions FINAL Page 18 Permit ID: 6-3022-00014/00031 Facility DEC ID: 6302200014 title I of the act and the changes do not exceed the emissions allowable under the permit (whether expressed therein as a rate of emissions or in terms of total emissions) provided that the facility provides the administrator and the department with written notification as required below in advance of the proposed changes within a minimum of seven days. The facility owner or operator, and the department shall attach each such notice to their copy of the relevant permit. (i) For each such change, the written notification required above shall include a brief description of the change within the permitted facility, the date on which the change will occur, any change in emissions, and any permit term or condition that is no longer applicable as a result of the change. (ii) The permit shield described in section 6 NYCRR 201-6.6 shall not apply to any change made pursuant to this paragraph. Condition 19: Required Emissions Tests Effective between the dates of 04/19/2011 and 04/18/2016 Applicable Federal Requirement:6 NYCRR 202-1.1 Item 19.1: For the purpose of ascertaining compliance or non-compliance with any air pollution control code, rule or regulation, the commissioner may require the person who owns such air contamination source to submit an acceptable report of measured emissions within a stated time. Condition 20: Visible Emissions Limited Effective between the dates of 04/19/2011 and 04/18/2016 Applicable Federal Requirement:6 NYCRR 211.3 Item 20.1: Except as permitted by a specific part of this Subchapter and for open fires for which a restricted burning permit has been issued, no person shall cause or allow any air contamination source to emit any material having an opacity equal to or greater than 20 percent (six minute average) except for one continuous six-minute period per hour of not more than 57 percent opacity. Condition 21: Accidental release provisions. Effective between the dates of 04/19/2011 and 04/18/2016 Applicable Federal Requirement:40 CFR Part 68 Item 21.1: If a chemical is listed in Tables 1,2,3 or 4 of 40 CFR §68.130 is present in a process in quantities greater than the threshold quantity listed in Tables 1,2,3 or 4, the following requirements will apply: a) The owner or operator shall comply with the provisions of 40 CFR Part 68 and; b) The owner or operator shall submit at the time of permit issuance (if not previously submitted) one of the following, if such quantities are present: 1) A compliance schedule for meeting the requirements of 40 CFR Part 68 by the date provided Renewal 2 Air Pollution Control Permit Conditions FINAL Page 19 Permit ID: 6-3022-00014/00031 Facility DEC ID: 6302200014 in 40 CFR §68.10(a) or, 2) A certification statement that the source is in compliance with all requirements of 40 CFR Part 68, including the registration and submission of the Risk Management Plan. Information should be submitted to: Risk Management Plan Reporting Center C/O CSC 8400 Corporate Dr Carrollton, Md. 20785 Condition 22: Recycling and Emissions Reduction Effective between the dates of 04/19/2011 and 04/18/2016 Applicable Federal Requirement:40CFR 82, Subpart F Item 22.1: The permittee shall comply with all applicable provisions of 40 CFR Part 82. The following conditions are subject to annual compliance certification requirements for Title V permits only. Condition 23: Exempt and Trivial Activities Applicability Effective between the dates of 04/19/2011 and 04/18/2016 Applicable Federal Requirement:6 NYCRR 201-3.1 (a) Item 23.1: If the facility owner and/or operator performs any of the exempt and trivial activities listed in 6 NYCRR Part 201-3.2(c) or 201-3.3(c), such activities are exempt from the permitting provisions of 6 NYCRR Part 201-5, but not from other Parts of 6 NYCRR Chapter III, or from applicable permitting requirements of local air pollution control agencies. Condition 24: Emission Unit Definition Effective between the dates of 04/19/2011 and 04/18/2016 Applicable Federal Requirement:6 NYCRR Subpart 201-6 Item 24.1: The facility is authorized to perform regulated processes under this permit for: Emission Unit: U-00001 Emission Unit Description: This emission unit consists of a Cleaver-Brooks 25 MMBTU/hr Package Boiler. This boiler is fired on #2 fuel oil. Building(s): 5 Renewal 2 Air Pollution Control Permit Conditions FINAL Page 20 Permit ID: 6-3022-00014/00031 Facility DEC ID: 6302200014 Item 24.2: The facility is authorized to perform regulated processes under this permit for: Emission Unit: U-00002 Emission Unit Description: This emission unit consists of the manufacture of Pressure Sensitive Tape in the Expandover Fabric Coating Operation. Three coatings are applied to this web. Building(s): 1 Item 24.3: The facility is authorized to perform regulated processes under this permit for: Emission Unit: U-00006 Emission Unit Description: This emission unit consists of the manufacture of intubation devices, called "PEGS and Enteral Access". Bonding, coating and Inkjet Printing Operations occur here. Building(s): 5 Item 24.4: The facility is authorized to perform regulated processes under this permit for: Emission Unit: U-00007 Emission Unit Description: This emission unit consists of the formulation and mixing operations of hydrophyllic wound dressings: "Aqua-Flo" and "Curafil". Building(s): 2 Item 24.5: The facility is authorized to perform regulated processes under this permit for: Emission Unit: U-00008 Emission Unit Description: This emission unit consists of the formation of slabstock flexible polyurethane foam. This foam becomes the basis of Curafoam/Copa wound dressings. Building(s): 2 Condition 25: Compliance Certification Effective between the dates of 04/19/2011 and 04/18/2016 Applicable Federal Requirement:6 NYCRR 201-6.5 (f) Item 25.1: The Compliance Certification activity will be performed for the Facility. Item 25.2: Compliance Certification shall include the following monitoring: Renewal 2 Air Pollution Control Permit Conditions FINAL Page 21 Permit ID: 6-3022-00014/00031 Facility DEC ID: 6302200014 Monitoring Type: RECORD KEEPING/MAINTENANCE PROCEDURES Monitoring Description: (1) Certain changes and modifications which meet the criteria under subparagraphs (i)-(iii) of this paragraph may be conducted without prior approval of the department and shall not require modification of the permit. The facility owner and/or operator must however maintain records of the date and description of such changes and make such records available for review by department representatives upon request. (i) Changes that do not cause emissions to exceed any emission limitation contained in regulations or applicable requirements under this Title. (ii) Changes which do not cause the source to become subject to any additional regulations or requirements under this Title. (iii) Changes that do not seek to establish or modify a federally-enforceable emission cap or limit. (2) In addition to the recordkeeping required under paragraph (1) of this subdivision, the permittee must notify the department in writing at least 30 calendar days in advance of making changes involving: (i) the installation or relocation of any emission source, process, or emission points within a facility; (ii) the emission of any air pollutant not previously authorized or remitted in accordance with a permit issued by the department; (iii) the installation or alteration of any air cleaning installations, device or control equipment. (iv) the transition of an exclusively Research and Development process to a manufacturing process (prodicing commercial quantities of a product). (3) The department may require a permit modification to impose applicable requirements or special permit conditions if it determines that changes proposed pursuant to notification under paragraph (2) of this subdivision do not meet the criteria under paragraph (1) of this subdivision or the change may have a significant air quality impact. In such cases the department may require that the permittee not undertake the proposed change until it completes a more detailed review of the change for air quality impacts and/or applicable requirements. The department shall respond to the permittee in writing with Renewal 2 Air Pollution Control Permit Conditions FINAL Page 22 Permit ID: 6-3022-00014/00031 Facility DEC ID: 6302200014 such a determination within 15 days of receipt of the 30 day advance notification from the permittee. The department's determination shall include a listing of information necessary to further review the proposed change. Monitoring Frequency: AS REQUIRED - SEE PERMIT MONITORING DESCRIPTION Reporting Requirements: AS REQUIRED - SEE MONITORING DESCRIPTION Condition 26: Non Applicable requirements Effective between the dates of 04/19/2011 and 04/18/2016 Applicable Federal Requirement:6 NYCRR 201-6.5 (g) Item 26.1: This section contains a summary of those requirements that have been specifically identified as being not applicable to this facility and/or emission units, emission points, processes and/or emission sources within this facility. The summary also includes a justification for classifying any such requirements as non-applicable. 6 NYCRR 228-1.8 Reason: Part 228 does not apply to either Emission Unit U-00006 or Process 008(Enteral Access & PEGs) because these intubation tubes being coated are "Miscellaneous Plastic Parts" (Table 2 in 6 NYCRR 228-1.8) and this facility has capped VOC emissions below the 50 ton/yr threshold. 40 CFR Part 63, Subpart HHHHHH Reason: At the time of this application for Renewal #2, Tyco reports that they do not use coatings whose formulations include any compounds of the "target HAPs" (cadmuim, chromium, lead, manganese and nickel) per 40 CFR 63 Subpart HHHHHH; therefore Subpart HHHHHH does not apply to this facility. If at any time in the future, any target HAP might be formulated into a coating, or if a methylene chloride chemical stripper were to be utilized, then Subpart HHHHHH would apply. Condition 27: Facility Permissible Emissions Effective between the dates of 04/19/2011 and 04/18/2016 Applicable Federal Requirement:6 NYCRR 201-7.2 Item 27.1: The sum of emissions from the emission units specified in this permit shall not equal or exceed the following Potential To Emit (PTE) rate for each regulated contaminant: CAS No: 0NY100-00-0 Renewal 2 PTE: 49,000 pounds per year Air Pollution Control Permit Conditions FINAL Page 23 Permit ID: 6-3022-00014/00031 Facility DEC ID: 6302200014 Name: HAP CAS No: 0NY998-00-0 Name: VOC Condition 28: PTE: 99,800 pounds per year Capping Monitoring Condition Effective between the dates of 04/19/2011 and 04/18/2016 Applicable Federal Requirement:6 NYCRR 201-7.2 Item 28.1: Under the authority of 6 NYCRR Part 201-7, this condition contains an emission cap for the purpose of limiting emissions from the facility, emission unit or process to avoid being subject to the following applicable requirement(s) that the facility, emission unit or process would otherwise be subject to: 6 NYCRR 212.10 (a) (2) 6 NYCRR 228-1.3 (a) Item 28.2: Operation of this facility shall take place in accordance with the approved criteria, emission limits, terms, conditions and standards in this permit. Item 28.3: The owner or operator of the permitted facility must maintain all required records on-site for a period of five years and make them available to representatives of the Department upon request. Department representatives must be granted access to any facility regulated by this Subpart, during normal operating hours, for the purpose of determining compliance with this and any other state and federal air pollution control requirements, regulations or law. Item 28.4: On an annual basis, unless otherwise specified below, beginning one year after the granting of an emissions cap, the responsible official shall provide a certification to the Department that the facility has operated all emission units within the limits imposed by the emission cap. This certification shall include a brief summary of the emissions subject to the cap for that time period and a comparison to the threshold levels that would require compliance with an applicable requirement. Item 28.5: The emission of pollutants that exceed the applicability thresholds for an applicable requirement, for which the facility has obtained an emissions cap, constitutes a violation of Part 201 and of the Act. Item 28.6: The Compliance Certification activity will be performed for the Facility. Regulated Contaminant(s): CAS No: 0NY998-00-0 VOC Item 28.7: Compliance Certification shall include the following monitoring: Renewal 2 Air Pollution Control Permit Conditions FINAL Page 24 Permit ID: 6-3022-00014/00031 Facility DEC ID: 6302200014 Capping: Yes Monitoring Type: MONITORING OF PROCESS OR CONTROL DEVICE PARAMETERS AS SURROGATE Monitoring Description: The sum of VOC emissions from all emission units specified in this permit shall not exceed the potential to emit (PTE) of 99,800 pounds per consequtive 12-month period. To verify this limit, the records of material usage and production rates shall be used from the Expandover Coating Line, the PEGs and Enteral Access Assembly Line, as well as the PTE of all other VOC process sources. This cap will allow the facility to avoid the Part 212 VOC RACT requirements for general process sources throughout the entire facility and Part 228 VOC RACT requirements for emission unit U-00006. Parameter Monitored: VOC Upper Permit Limit: 99,800 pounds per year Monitoring Frequency: MONTHLY Averaging Method: ANNUAL MAXIMUM ROLLED MONTHLY Reporting Requirements: SEMI-ANNUALLY (CALENDAR) Reports due 30 days after the reporting period. The initial report is due 7/30/2011. Subsequent reports are due every 6 calendar month(s). Condition 29: Capping Monitoring Condition Effective between the dates of 04/19/2011 and 04/18/2016 Applicable Federal Requirement:6 NYCRR 201-7.2 Item 29.1: Under the authority of 6 NYCRR Part 201-7, this condition contains an emission cap for the purpose of limiting emissions from the facility, emission unit or process to avoid being subject to the following applicable requirement(s) that the facility, emission unit or process would otherwise be subject to: 40 CFR Part 63, Subpart JJJJ 40 CFR Part 63, Subpart OOOO Item 29.2: Operation of this facility shall take place in accordance with the approved criteria, emission limits, terms, conditions and standards in this permit. Item 29.3: The owner or operator of the permitted facility must maintain all required records on-site for a period of five years and make them available to representatives of the Department upon request. Department representatives must be granted access to any facility regulated by this Subpart, during normal operating hours, for the purpose of determining compliance with this and any other state and federal air pollution control requirements, regulations or law. Item 29.4: On an annual basis, unless otherwise specified below, beginning one year after the granting of an Renewal 2 Air Pollution Control Permit Conditions FINAL Page 25 Permit ID: 6-3022-00014/00031 Facility DEC ID: 6302200014 emissions cap, the responsible official shall provide a certification to the Department that the facility has operated all emission units within the limits imposed by the emission cap. This certification shall include a brief summary of the emissions subject to the cap for that time period and a comparison to the threshold levels that would require compliance with an applicable requirement. Item 29.5: The emission of pollutants that exceed the applicability thresholds for an applicable requirement, for which the facility has obtained an emissions cap, constitutes a violation of Part 201 and of the Act. Item 29.6: The Compliance Certification activity will be performed for the Facility. Regulated Contaminant(s): CAS No: 0NY100-00-0 HAP Item 29.7: Compliance Certification shall include the following monitoring: Capping: Yes Monitoring Type: RECORD KEEPING/MAINTENANCE PROCEDURES Monitoring Description: Emissions of speciated hazardous air pollutants (HAPs) shall not exceed 9.5 tons during any 12-month rolling period and aggregate HAP emissions shall not exceed 24.5 tons during any 12-month rolling period. These caps will exempt the facility from all MACT standards (40 CFR Part 63) with a compliance date on or after December 5, 2005. Tyco will verify compliance with these HAP emission caps on a 12-month rolling basis by applying determined HAP emission factors to the following: * Number 2 fuel oil usage for the boiler (EP-00001). * Monthly records of adhesive usage for the Expandover Coating operation (EP-00002). * Conservative potential monthly emissions for the exempt instrument laboratory hoods (EP-00008, EP-00011 and EP-00012). * Monthly records of Hydromer, DOT Ink and Pad Ink usage for the PEGS and Enternal Access equipment (EP-00020). * Conservative potential monthly emissions for the Aqua-Flo (EP-00021) and the Curafoam (EP-00025) processes. · Conservative potential monthly e

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