Regulatory Affairs Manual
Ozone Depleting Substance Guidelines
Series 100
Program 109.01

F I SH ER SC I EN TI F I C
2000 Park Lane
Pittsburgh, Pennsylvania 15275
Phone 412.490.8300 • Fax 412.490.8930

Regulatory Affairs Manual
Ozone Depleting Substance Guidelines
Series 100
Program 109.01
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11 Reporting Documents:
Forms:
See Forms F109.01-F109.04 in Forms Section of Regulatory Affairs Manual
Appendix A: Definitions
Appendix A: Definitions
Appendix B: Federal Regulations
Appendix C: EPA Industrial Process Refrigeration Compliance Guide
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Effective Date: April 2004
Revision Date: August 2004
Rev. # 2 Mandatory  Discretionary  i

Regulatory Affairs Manual
Ozone Depleting Substance Guidelines
Series 100
Program 109.01
This guideline is organized into several distinct sections to assist in the review of sections applicable to each facility or corporate group. A brief description of the organization of the guidelines is as follows:
Facility Level Requirements
I. Maintenance and Repair of ODS Containing Equipment – Requirements applicable to facilities with commercially owned Ozone Depleting Substances (ODS) containing equipment (this includes refrigeration units, air conditioners, and lyophilizers) are addressed in this section, including record keeping, reporting, and certification requirements. Includes sections on the regulatory requirements associated with the maintenance and repair of ODS containing equipment.
Corporate Level Guidelines
II.
ODS Regulatory Requirements Guidance
– Additional detail on the regulatory requirements associated with the use, sale, and purchase of ozone depleting substances.
Includes sections on the sale, purchase, and distribution of ODS (e.g. import and export requirements).
III.
Export Documentation Requirements – A listing of all the necessary documents involved in record keeping and reporting for ODS export.
IV.
Import Documentation Requirements
– A listing of all the necessary documents involved in record keeping and reporting for ODS import.
V.
Forms – Template forms for facility usage in appropriately documenting the inventory and maintenance/repair activities of ODS containing equipment.
Appendix A:
Definitions – a description of terms referenced in this guideline.
Appendix B:
Federal Regulations – Attached copies of the federal regulations cited in this document.
Appendix C:
EPA Industrial Process Refrigeration Compliance Guide – Refrigerant Leak Repair Flow
Chart
Effective Date: April 2004
Revision Date: August 2004
Rev. # 2 Mandatory  Discretionary 
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Regulatory Affairs Manual
Ozone Depleting Substance Guidelines
Series 100
Program 109.01
The following guidelines apply to facilities which have pieces of equipment with a normal requirement charge equaling or exceeding 50 pounds of Class I or Class II refrigerant charge.
This includes most lyophilizers and cooling equipment. When in doubt, consult owner’s manuals or information posted on the unit itself. An inventory of this equipment should be maintained on file, such as the one included as Form F109.04
.
Maintenance activities (any activity other than those which are considered normal use of the equipment for the designed purpose including repair work, fluid changing, cleaning) are to be completed by certified individuals only, and all activities are to be recorded and maintained at the specified piece of equipment for no less than 3 years.
All maintenance work should be done in accordance with properly developed Standard Operating
Procedures for the specified piece of equipment. The following outlines how maintenance records should be created and retained.
1.0
MAINTENANCE AND REPAIR OF ODS CONTAINING EQUIPMENT
Leak repair requirements apply to each independent refrigerant circuit containing greater than or equal to 50 pounds of refrigerant. A refrigerant circuit consists of equipment that carries refrigerant (typically in a closed loop) to and from the point of cooling. For example, refrigerant may flow from a compressor to components, such as heat exchangers and evaporators, and back to the compressor. These circuits are considered to be independent if the refrigerant in one circuit does not mix with the refrigerant in other circuits.
1.1 General Requirements

Quantities of ODS in all records must be recorded in pounds (lbs.).

Leak rates must be recorded in percentage per annum. This can be in addition to more standard notations (volume of refrigerant lost per time) as long as the annual rate is recorded in conjunction.

All records required by these guidelines must be maintained for a minimum of 3 years regardless of whether or not the equipment is still in service.
1.2 General Maintenance and Repair Requirements
1.2.1 General

Servicing individuals may be either employees or outside contractors provided that they have had proper training and a current certification on file with their employer. o Employee Performed Service :
 Complete Employee ODS Certification Form ( F109.01
) and maintain in file at facility.
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Revision Date: August 2004
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Ozone Depleting Substance Guidelines
Series 100
Program 109.01
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Use Equipment Maintenance by Employee Form ( F109.02
); attach any necessary documents, to appropriately record maintenance activities.
 File the completed maintenance form in a log book for the maintained unit at the facility. o Outside Contractor Performed Service :
 Have contractor complete Equipment Maintenance by Outside
Contractor Form ( F109.03
) each time service is performed and attach a copy of their invoice.
 File the completed form for the maintained unit at the facility.

At time of service, each piece of equipment shall be tested for leaks, and if leaks are found they must be documented on the appropriate service form (either
F109.02 or F109.03
depending on who performs the service). The annual leak rate will also be recorded on the service form.
1.2.2 Record Keeping
Each time a piece of ODS containing equipment is serviced, either by an outside contractor or an employee; an Equipment Maintenance Form must be completed
( F109.02 or F109.03
). Completion and maintenance of this form will ensure required information is collected and maintained for the equipment. a leak rate calculation must be done at the time the equipment is serviced. Other noted record keeping requirements include:

Forms ( F109.02 or F109.03
) relevant to repair and maintenance activities must be prepared by the technician providing service if the technician is an employee, or by the employee responsible for overseeing the performance of the outside contractor.

Information relevant to the affected appliance must be maintained, including: o identification of the facility, o full charge of refrigerant required for the system to operate, o method used to determine full charge, o leak rate, o method used to determine the leak rate, o date a leak rate exceeding the allowable annual leak rate was discovered, o location of the leak, o specific repair steps, o date that work was completed and initial verification test conducted to demonstrate that the leak was repaired, o date of the follow-up verification test to demonstrate that the leak repair held, o and plan to complete the retrofit or replacement of the system, if verification testing shows that the leak was not repaired.

Each piece of equipment should have a binder or archiving tool at its location containing all appropriate completed forms and schedules. Outside contractors providing maintenance work are required to submit invoices which should detail
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Ozone Depleting Substance Guidelines
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Program 109.01
the services they provided, including the unit serviced and all relevant information regarding leak rates and amount of refrigerant added to, or removed from, a piece of equipment. Copies of those invoices should be attached to the forms and filed accordingly.

All records of any repair or service to a piece of equipment subject to these guidelines will be saved and filed.
1.2.3 Reporting
Reports must be filed with the EPA when necessary repairs are not made in the time allotted in these guidelines, or when there is a plan to replace or retrofit an existing piece of equipment. These times are outlined in the Detailed Maintenance and Repair
Requirements section, Section 1.3.
1.2.4
Certification

Certified employees must have a copy of their certification and a completed
Employee ODS Certification Form ( Form F109.01
) on file in their facility employment file. Each should also carry with them the wallet sized card they were issued at time of certification.

All outside contractors must be certified to perform maintenance and must use certified equipment. Documentation of certification (for both persons conducting the work and the equipment they will be using) in the form of a copy of the certificate, if appropriate, should be obtained from the contractor prior to their
 selection. Documentation for personnel should contain reference to certification conducted under the guidelines of 40 CFR Part 82 Subpart F Appendix D. A signed letter from the contractor performing the maintenance stating that all equipment is compliance with the regulations listed below is sufficient and minimizes the amount of paperwork maintained at the facility.
Any piece of equipment used to capture, destroy, or recycle refrigerants must be certified in accordance with 40 CFR Section 82.158 and registered under 40 CFR
Section 82.162; both included in Appendix B. The EPA recognizes equipment manufactured since 1998 as complying with all necessary regulations and do not need to seek registration. Equipment manufactured prior to 1998 must be certified and registered. Where the facility owns the equipment, copies of certifications, or an owner’s manual, if it is to serve as certification, must be maintained on file for all such equipment.
1.2.5 Handling of Waste Oil
Waste oils associated with the routine maintenance of ODS equipment should be stored in an appropriately labeled container separate from other waste oils generated at the facility due to the potential for refrigerant contamination of the oil. This container should be labeled as “Waste Oil associated with ODS Equipment.” Prior to disposal, these waste oils should be tested for total halogen content to ensure appropriate disposal. If testing shows that the total halogen content is greater than 1000 ppm, additional analyses should be conducted to verify that the halogens are coming from the refrigerant and are not hazardous wastes. The additional testing should be conducted for the 29 purgeable halocarbons listed under Method 601 of 40 C.F.R Part 136. As long as each of the halogenated hazardous constituents is present in concentrations below 100 ppm, the
Effective Date: April 2004
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facility has demonstrated that the waste oil associated with ODS equipment has not been mixed with hazardous waste.
1.3 Detailed Maintenance and Repair Requirements
1.3.1 ODS Leaking Equipment
The maximum allowable annual leak rate is a measure of how much of a unit’s required operating refrigerant is lost due to leakage over a 12 month period. The acceptable value varies based on the type of equipment considered, as outlined below:

35% leakage per year for industrial process and commercial refrigeration equipment (e.g. lyophilizers, product refrigerators, product freezers, air conditioners--see definitions in Section IV for additional details), and

15% per year for equipment not falling into either of those two categories but still requiring more than 50 lbs of refrigerant for normal operation.
All leaks must be repaired within 30 days of the leak being detected . If it appears that a leak will not be repaired within the 30-day window, notify Regulatory Affairs as soon as possible, but no later than 14 days after detection of the leak to address additional potential reporting requirements. A Refrigerant Leak Repair Flow Chart is included as
Appendix C for reference.
Purged refrigerants that are destroyed can be excluded from annual leak calculations if appropriate records are maintained. Such records include:

Identification of the facility and contact person, including address and telephone number;

General description of refrigerant appliance;

Description of methods used to determine quantity of refrigerant sent for destruction;

Frequency of monitoring and data-recording; and

Description of control device and its destruction efficiency.
Appliances that are required to be opened for maintenance, service, or repair (except for small appliances less than 5 pounds of charge) must evacuate the refrigerant to acceptable levels (see Table I in Appendix B) to a certified recovery or recycling machine. Small appliances that are required to be opened for maintenance, service, or repair must recover an appropriate amount of the refrigerant in the appliance (80% if recovery equipment was manufactured before 15 November 1993, or 90% if recovery equipment was manufactured after 15 November 1993).
Any equipment exceeding the allowable annual leak rate must be repaired within 30 days of when the problem was, or should have been, noticed. The appropriate Equipment
Maintenance Form ( Form F109.02 or F109.03
) must be completed when performing repairs. After 30 days, the equipment must function at a leak rate below the acceptable value. The 30-day limit is extendable under the following conditions:
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Ozone Depleting Substance Guidelines
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Program 109.01

It will take longer than 30 days for the required part to be available to repair the problem, in which case 120 days is allowed and documentation of the delay is required;
 If the facility is shut down, 120 days are available for repairs;
 A one-year retrofit or retirement plan for the leaking equipment is developed. This plan must be kept at the site of the unit, with an original available to EPA for inspection at their request. The plan must be dated and all work completed under the plan within one year of the plan’s date. The one year term pertains unless one of the following exceptions exist:
 The equipment has undergone mothballing. The time for completion of repairs or retrofit will resume on the day the equipment is brought back on-line.
 Additional time, to the extent reasonably necessary, is allowed if there are delays related to other federal, state, or local laws and regulations or due to the unavailability of a suitable replacement refrigerant with lower ozone depletion potential. If either of these circumstances applies, the owner/operator must notify the EPA within six months of the initial 30day period following detection of the leak. Records demonstrating the above must be submitted to the Administrator. The EPA will notify the owner/operator of its determination within 60 days of receipt the submittal.

An additional one year period beyond the initial one year retrofit is permissible for industrial process equipment where the following criteria are met:

The equipment proposed to replace the existing equipment is custom built,

Supplier of equipment or of critical components has quoted a delivery time of more than 30 weeks from order placement,

During the first 6 months after the expiration of the initial 30-day period, the EPA is notified, the appliance is described, a reasonable explanation of why over one year is required for repair is supplied, and the first two criteria above are demonstrated. Records must be maintained that are adequate to allow a determination that the criteria are met.

OR, if the equipment is in an area subject to radiological contamination and creating a safe working environment will take more than 30 weeks.

If the additional year is awarded it may be extended if a request is submitted in writing to the EPA before the end of the 9 th month of the first additional year and shall include revisions of the required information for the first additional year.
Unless the EPA rejects the submission within 30 days of receipt, it shall be approved.
If successful equipment repair is not completed within the initial 30 days of discovery, the Regulatory Affairs department should be contacted immediately.
1.3.2 Verification Testing
A repaired piece of Industrial Process Equipment must submit to an initial verification test and a follow-up verification test 30 days later conducted at normal operating conditions. Verification test dates and results should be recorded on the appropriate
Equipment Maintenance Form ( Form F109.02 or F109.03
). The follow-up test may be conducted at other than operating conditions if sound professional judgment deems the
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Ozone Depleting Substance Guidelines
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Program 109.01
results to be more reliable, but must be conducted at normal operating temperature and pressure.
Any methodology that meets sound professional judgment may be used for the verification testing. Examples of acceptable test methods include, but are not limited to:

Soap bubble test; or

Electronic leak detectors; or

Ultrasonic leak detectors; or

A pressure test; or

A vacuum test; or

A fluorescent dye and black light test; or

An infrared test; or

A near infrared (back scatter absorption gas imaging) test; or

Halon refrigerant gas detection methods.
Initial Verification Testing
An initial verification test is to be done after any leak repair to demonstrate that the repair was successful. If the refrigerant was evacuated prior to repairing the leak, the initial verification test must be done before the full charge of refrigerant is replaced. If evacuation was not necessary, the test should be conducted as soon as practicable. Any of the above methods can be used, but the date of the test must be documented on Form
F109.02 or F109.03
.
Follow-up Verification Testing
The follow-up verification test is conducted within 30 days of the leak repair to confirm that the repairs made continue to hold once the equipment returns to normal operating characteristics or conditions. The test must be done either 1) within 30 days after the initial verification when normal operating conditions are maintained, or 2) within 30 days after bringing the equipment back on-line and it is at normal conditions. If it is determined that the results of the follow-up verification are not be reliable when the test is conducted at normal operating conditions (e.g. a repair made to leak inside a heat exchanger), the follow-up verification may be conducted prior to returning to normal operations conditions provided normal operating pressure and temperature are maintained. Again, any of the above methods can be used, but the date of the test must be documented on Form F109.02 or F109.03
.
Additional information relating to verification testing includes:

If a piece of Industrial Process Equipment is taken off-line, it cannot be brought back online until the leaks are repaired to an acceptable level, or retrofit plan has been put in place.

If the Industrial Process Equipment does not pass the initial verification test, the owner is responsible for implementing a one year retrofit/replacement plan as discussed in Section 1.3.1. Under only two conditions is this not the case:
 A retrofit plan is not required if the same leak can be repaired a second time and pass a verification test within the initial 30 or 120 day repair period, whichever is relevant. After the 30-day follow-up verification, the EPA must be notified, and the obligation to retrofit or replace no longer exists.
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
If within 180 days of the failed follow-up test the equipment is shown to have an acceptable leak rate (when beginning with the amount of refrigerant specified by the manufacturer in the manual or instructions), and within 30 days of that realization the EPA is properly notified, it is not required to retrofit or replace the unit.
Effective Date: April 2004
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2.0
SALE, PURCHASE, AND DISTRIBUTION OF ODS
All persons who sell or distribute any class I or class II substance for use as a refrigerant must retain invoices that indicate the name of the purchaser, the date of sale, and the quantity of refrigerant purchased.
The import and export requirements apply to the transaction of ODS for use in other than laboratory functions. Activities pertaining to laboratory functions are subject to section 2.3,
Essential Use.
2.1 Import Requirements
The import of ODS may be subject to international laws and regulations not covered in this document, it is advised that those regulations be researched and applied. Where noted, additional information must be provided if the import consists of used, recycled, or reclaimed controlled substances.
2.1.1.Recordkeeping
Documents, where appropriate, must be kept on file for at least 3 years regarding imports of Class I controlled substances. The list of specific documents can be found in Section
V.
2.1.2 Reporting
In cases where the import contains used, recycled or reclaimed ODS, the importer must submit appropriate records to the Administrator at least 15 days prior to the shipment leaving its port of export for each individual shipment over 150 pounds. The
Administrator will assess the petition and within 15 days pass judgment. No response allows the shipment to occur as scheduled. If the Administrator objects, the importer may repetition.
Also, within 45 days of the end of the quarter, a report summarizing all imported Class I controlled substances must be submitted to the Administrator. The report must contain the reporting information found in Section V.
2.2 Export Requirements
The export of ODS may be subject to international laws and regulations not covered in this document, therefore, it is advised that those regulations be researched and applied, as appropriate.
2.2.1 Record keeping
The documents listed in Section V regarding Import Records need to be retained in addition to the items listed in Section IV. All documents should be retained for a minimum of 3 years.
2.2.2 Reporting
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Within 45 days of the end of the control period (annually, thus reporting date is 15
February), the information listed in Section IV under Reporting is required to be submitted to the Administrator:
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Recordkeeping Documents:

The name and quantity of each controlled substance imported including the percentage of each mixture which consists of a controlled substance,

Quantity of controlled substances other than transshipments or used, recycled or reclaimed substances imported for use in processes resulting in their transformation or destruction and quantity sold for use in processes that result in

 their destruction or transformation,
Date on which controlled substances were imported,
Port of entry through which the controlled substances passed,

The country from which the imported controlled substances were imported,

Commodity code for controlled substances shipped,

Importer number for shipment,

Copies of bill of lading for import,

Invoice for the import,

Quantity of imports of used, recycled or reclaimed class I controlled substances and class II controlled substances and the contact information for the foreign reclamation facility and associated contact person, if applicable,

U.S. customs entry form,

Dated records documenting sale or transfer of controlled substances for use in processes resulting in transformation or destruction,

Copies of IRS certifications that controlled substance will be transformed or destruction verifications that it will be destroyed,

Where applicable, the intended use of used, recycled, or reclaimed substances,

The contact information for the US reclamation facility and a certification of their tax liability if applicable,

Dated records of quantity of controlled substances imported for essential use or imported with destruction or transformation credits, and

Copies of certifications that imported controlled substances are being purchased for essential laboratory (if applicable) and analytical applications or being purchased for eventual sale to laboratories that certify the controlled substances are for essential laboratory applications.
Reporting Documents:

Summaries of the records required in 2.1.1 for the previous quarter,

The total quantity imported in kilograms of each controlled substance for that quarter,

The quantity of those controlled substances imported that are used controlled substances,

The levels of import of controlled substances for that quarter and totaled by chemical for the control-period-to-date,

The amount of ODS imported for use in processes resulting in their transformation or destruction,

The amount of controlled substances sold or transferred during the quarter to each person for use in processes resulting in their transformation or eventual destruction,
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The amount of controlled substances sold or transferred during the quarter to each person for an essential use,

The amount of controlled substances imported with destruction and transformation credits,

Internal Revenue Service Certificates showing that the purchaser or recipient of imported controlled substances intends to transform those substances or destruction verifications showing that purchaser or recipient intends to destroy the controlled substances, and

The certifications from essential-use allowance holders stating that the controlled substances were purchased solely for specified essential-uses and will not be resold or used in manufacturing; and the certifications from distributors of laboratory supplies that the controlled substances were purchased solely for eventual sale to laboratories that certify the controlled substances are for essential laboratory and analytical uses, or if sales are made directly to laboratories, certifications from laboratories that the controlled substances will only be used for essential laboratory and analytical uses and will not be resold or used in manufacturing.
Importers of Class II chemicals must report quarterly levels of imports within 45 days of the end of each quarter.
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Recordkeeping Documents:

Identities and addresses of the exporter and Article 5 country recipient,
 Exporter’s employee identification number,

Names and phone numbers of contact persons for exporter and recipient,

Quantity and type of substance exported with documentation of source and date purchased,

Date and port on which the substance was exported from the US or its territories,

Article 5 country to which the shipment was made,

Copy of bill of lading and invoice indicating net quantity shipped and documenting sale,

Commodity code of exported substance, and

Copy of sales agreement covering the sale which contains provisions forbidding the re-export of the substance in bulk form and subjecting the recipient or any transferee of the recipient to liquidated damages equal to the resale price of the substance if re-exported in bulk form.
Reporting Documents:

The names and addresses of the exporter and the recipient of the exports;
 The exporter’s Employee Identification Number;

The type and quantity of each controlled substance exported and what percentage, if any, of the controlled substance is used, recycled or reclaimed;

The date on which, and the port from which, the controlled substances were exported from the United States;

The country to which the controlled substances were exported;


The amount exported to each Article 5 country ;
The commodity code of the controlled substance shipped; and

The invoice or sales agreement containing language similar to the IRS Certificate that the purchaser or recipient of imported controlled substances intends to transform those substances, or destruction verifications showing that the purchaser or recipient intends to destroy the controlled substances.
Exporters of Class II chemicals must report quarterly levels of exports of these chemicals within
45 days of the end of each quarter.
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