SECTION A: GENERAL FACILITY INFORMATION
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| Janssen Ortho LLC
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| Johnson & Johnson
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| | Mr. Sandy Casillas |
| | Acting, Environmental Affairs Supervisor |
| | (787) 272-7413 |
| | (787) 272-7435 |
| | scasill2@janpr.jnj.com |
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| | Road 933 KM 0.1 Mamey Ward |
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| | Gurabo |
| | PR |
| | 00778-9629
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| | HC 02 Box 19250 |
| | Mamey Ward |
| | Gurabo |
| | PR |
| | 00778-9629 |
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| http://www.janssen.com
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| 500-1,000
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| 334514
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| No
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| No
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| 2004
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| 2005
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An internal assessment was conducted with two purposes: verify compliance status with ISO-14001 Environmental Management System and to complete the Managent Action Plan, which is a self-assessment for the TRAC (TRAC stands for Total Risk Assessment and Control).
This application is part of Johnson & Johnson's continuing effort to reduce and eliminate risk through facility-based compliance assessments.
TRAC was originally conceived for the Management Awareness and Action Review System (MAARS). It is used by the following disciplines to monitor compliance with regulations and Johnson & Johnson policy for environment, health, safety, security, and privacy:
--Worldwide Health & Safety
--Worldwide Security Group
--Worldwide Environmental Affairs
--Corporate Office of Privacy
--Health Care Compliance
--Information Lifecycle Management
--Worldwide Information Security
The versatile nature of this assessment engine makes it ideal for use by any corporate department with governance responsibility. | December 2005 |
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| 2005
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An internal assessment was conducted with two purposes: verify compliance status with Janssen Ortho LLC ISO-14001 Program and to complete the MAP, which is a self-assessment for the TRACK (TRAC stands for Total Risk Assessment and Control).
This application is part of Johnson & Johnson's continuing effort to reduce and eliminate risk through facility-based compliance assessments.
TRAC was originally conceived for the Management Awareness and Action Review System (MAARS). It is used by the following disciplines to monitor compliance with regulations and Johnson & Johnson policy for environment, health, safety, security, and privacy:
--Worldwide Health & Safety
--Worldwide Security Group
--Worldwide Environmental Affairs
--Corporate Office of Privacy
--Health Care Compliance
--Information Lifecycle Management
--Worldwide Information Security
The versatile nature of this assessment engine makes it ideal for use by any corporate department with governance responsibility. | August 2005 | ERM (external environmental professional services firm) and facility staff. |
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02-07-05 Environmental Quality Board (EQB): RCRA Inspection. The site was found in compliance with the local hazardous waste regulation at the time of the inspection.
02-14-05 EQB Air Quality Inspection. A notice of violation was issued indicating that two emergency generators were found onsite without a permit to construct/operate. However, after response to EQB, the inspector and his/her supervisor confirmed that they were not referring the case to their legal department because the site demonstrated that the emergency generators were installed in substitution of one emergency generator (under repair) who's capacity was higher than both emergency generators added. Later, the emergency generators were removed, because they were installed temporarily until the main generator with more capacity was repaired. The Agency concluded that they would visit the site to make sure that the two generators were removed.
04-13-05 Puerto RicoDepartment of Health (DOH) Inspection for a bacteriological sampling at the drinking water distribution system. Residual chlorine was tested on site and was within regulatory limit. No observations were found.
04-28-05 Puerto Rico Aqueduct and Sewer Authority(PRASA) Regulatory Sampling. Samples were taken from Discharge 001 & Stream Flow 001 which is the discharge point to the POTW. No observations were found.
05-20-05 Department of Natural and Environmental Resources (DNER)Inspection to complete the renewal of the franchise for the remediation wells.
06-01-05 DOH Inspection to conduct a bacteriological sampling at the drinking water distribution system. Residual chlorine was tested on site and was within regulatory limit. No observations were found.
06-08-05 DOH Inspection: An inspector of the agency visited the site for the renewal of the sanitary license of Cafeteria and Packaging of JII. The inspector pointed of containers labeling and is necessary to provide the Food Management course for all employees.
06-22-05 Puerto Rico Fire Department: Annual inspection. No observations were found.
09-07-04 PRASA Inspection: Regulatory inspection of the site wastewater treatment system. No observations were found.
09-19-05 DOH Inspection: Conduct a bacteriological sampling at the drinking water distribution system. No observations were found.
12-06-05 PRASA Inspection: Regulatory inspection of the site wastewater treatment system. No observations were found.
12-21-05 DOH Inspection: Verify the conditions of the Janssen I Cafeteria, in order to proceed an issue the license for its operation. The DOH License for the Janssen I Cafeteria was issued by mid-January 2006.
In addition to the above inspections, the Department of Treasury conducted monthly inspections of the inventory and usage of Ethyl Alcohol 200ยบ Proof.
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05-20-05 DNER Inspection: The payments for the water extracted under extraction wells authorized under the current franchise are being sent to the DNER on a monthly basis, as requested and with the franchise No. includeeed for reference.
06-08-05 DOH Inspection: Training on labeling of containers was provided by Aramark to their employees and also Food Management Course to several of their employees.
12-21-05 DOH Inspection: Aramark employees were trained by their supervisor on good housekeeping practices.
12-30-05 The EHS Policy was revised in accordance with Janssen Ortho LLC EMS with the major purpose of indicating the compromise of the organization not only with the employees health but also with the public's. In addition, since the name of the J&J Sector changed from Pharmaceutical Sourcing Group of Americas (PSGA) to Global Pharmaceutical Supply Group (GPSG), the change was also included.
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| Yes
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| December 05 |
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| Mr. Rafael Espinal |
| General Manager |
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| Yes
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| No |
| Janssen Ortho LLC's first commitment is to reduce the facility's total water use. |
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Approximately 40% of water discharge of the remediation treatment system have been reused internally for non-potable purposes. In addition, several projects (e.g., monitoring of water usage at different areas) and/or initiatives addressed to the reduction in water consumption were implemented. |
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Approximately 40% of water discharge of the remediation treatment system have been reused internally for non-potable purposes.
In addition a revision of the water bills revealed that JOLLC was paying various invoices of facilities formerly use by Janssen. Various accounts were cancelled and credits received from the actual users.
Normalization factor is based on 4755 MM Units produced in 2003 vs 5111 MM units produced in 2004. |
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| Janssen Ortho LLC's second commitment is to reduce the facility's materials use. This data is aggregated with that of three other PSGA manfucturing facilities (Ortho Pharmaceutical and Ortho Biologics of Manati, PR and Ortho Pharmaceutical in Raritan, NJ). The data is included in the report for the Raritan facility. |
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Site is focusing in the Design for the Environment (DfE) approach required by Johnson & Johnson for Planet 2010 Goals and the Efficiency Index (EI), which is a metric that takes into consideration the handling of materials received, quality control effective techniques/practices, manufacturing processes, storage of final products, etc. These practices and programs have been integrated within the Process Excellence initiatives. These initiatives seek for opportunities on process improvement, increase yield, reduce cycle time, control employee exposure and operating costs. Controlling all those have a positive impact in the site environmental performance. The Site's EI for Year 2005 was one of the highest's within the organization. |
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Site embraces the six sigma, lean thinking and design excellence approach. It is basically been integrated within the Process Excellence initiatives. This initiative seeks for opportunities on process improvement, increase yield, reduce cycle time, control employee exposure and operating costs. Controlling all those have a positive impact in the site environmental performance. Projects that have impact this goals are: Granulators yield improvement by 2-5%, Improvement in compressors stage thus eliminating rejects due to broken tablets, Automation of packaging lines, etc.
Normalization factor is based on 4755 MM Units produced in 2003 vs 5111 MM units produced in 2004.
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| Janssen Ortho LLC's third commitment is to reduce the facility's generation of non-hazardous waste. |
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The site is identifying and implementing reuse and recycling processes that are helping the achievement of the reduction of non-hazardous waste disposal. In addition, since the Efficiency Index and the Design for the Environment initiatives are being implemented, this have aid in the reduction of waste associated with raw materials and others that indirectly are associated with the disposal of discarded materials (e.g., plastic bags, drums). |
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Although a slight increase in the overall volume of waste was experienced during this year, site made significant efforts in manageing the waste through environmental-friendly management methods. Over 45% increase in recyclables materials compare with year 2003. Overall waste managemet practices represents that 35.04% of our non-hazardous waste is managed by preferred management method as described by J&J (i.e. reuse, recycle, incineration with energy recovery, etc.)
Normalization factor is based on 4755 MM Units produced in 2003 vs 5111 MM units produced in 2004. |
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| Janssen Ortho LLC's fourth commitment is to reduce the facility's generation of hazardous waste. |
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A reduction in hazardous waste was due to the implementation of the Design for the Environment tool, the Efficiency Index, and the practice of weighting the materials instead of use the volumes of the different containers.
DFE is a systematic process to identify and minimize the environmental impacts of products and processes throughout their entire life cycles. Has help the Environmental aspects in: Reducing risk; Reduce costs; Reduce time-to-profit; Eliminate the use of banned materials; Enhance Disassembly/Reuse/Recycle
Gain competitive advantage.
Efficiency Index or Ei, is an internal metric from the Pharmaceutical Sector within J&J, which is a way to measure how effectively we convert raw materials into finished goods. The ultimate goal is an Ei of 100%, which means that we are using all of our raw materials in our manufacturing processes with no waste. The closer we get to Ei 100 the better we are doing. Improving this metric we were able to reduce the generatioon of hazardous waste associated to cleaning process, such as Alcohol and rags, among others.
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An increase in volume of operation have impacted the generation of hazardous waste at the site. Particularly the integration of Quality Assurance testing from other pharmaceutical facilities of PR into the Janssen Ortho LLC operation have impacted this measurement. This testings required usage of solvents that shall be disposed of as hazardous waste. Opportunities for improvement will be evaluated during this year.
Normalization factor is based on 4755 MM Units produced in 2003 vs 5111 MM units produced in 2004. |
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In the table below, please provide a narrative summary of progress made toward EMS objectives and targets other than those reported as Environmental Performance Commitments. You may limit the summary to environmental aspects that are significant and towards which progress has been made during the reporting year.
Do you have additional environmental aspects to report? Yes
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| (e.g., quantitative or qualitative improvements, activities conducted) |
| 5-year Review Report from EPA Region 2 on CERCLA Remediation Project | EPA approved a proposal to shutdown two of the seven extraction wells, to eliminate the use of steam to treat the extracted groundwater, and to modify the monitoring frequency. As recommended by EPA, an analysis of the capture zone of the remaining five extraction wells is being conducted to ensure that the contaminant plume is fully captured at all depths. After that analysis is completed, according to EPA the groundwater extraction rates can be modified as appropriate. |
| New projects for expansions, new product/processes introduction, and utilities. | The site is undergoing several projects addressed to expansions, new technologies, and the installation of new utilities, one from which is a Cogeneration Unit. The environmental impacts of the construction related activities, the installation, and the operation of the projects have been all assessed and are being implemented as per each project schedule. The project names are: Parent, OROS/Glatt V, and Procrit/Quicksolv Expansion. As part of the Parent project, Janssen Ortho LLC will install a Cogeneration Unit to supply the required additional electric/steam power required for the operations. |
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| On April 21, 2005, Janssen Ortho LLC received from EPA an Environmental Quality Award, for protecting and enhancing environmental quality through the implementation and operation of the remediation project. This project has been recognized by EPA as a benchmark remediation project that started in April 1991 and its now in an operation and maintenance mode, which basically means that the project is close to the remediation goals.
In year 2005, we were able to donate near 150,000 gallons of potable water to the near by communities residents, we participate in different activities sponsored by the company with the community such as United Way; Activities sponsored by the PR Trust Foundation in seeding trees, and preseve natural reserves in the North part of the island.
One phone call was received from one neighbor relating to outside contractor situation, related to food left over management. We inmediately contacted the Contractor to solve the situation, and after that we had a meeting with the neighbor and the contractor to notify the action steps taken. Situation was solved satisfactory.
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| Web Site |
| URL: http://www.jnj.com/community/environment/awards/index.htm |
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OMB No. 2010-0032
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SECTION E: SELF-CERTIFICATION OF CONTINUED PROGRAM PARTICIPATION FOR ANNUAL PERFORMANCE REPORT
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The U.S. Environmental Protection Agency is not yet in a position to accept electronic signatures and therefore requests a faxed, signed copy of the Section E page. Please complete Section E online, then print Section E using the link on the Overview page. Section E should be signed by the senior manager of your facility and faxed it to the Performance Track Information Center at (617) 354-0463.
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On behalf of Janssen Ortho LLC, I certify that:
- I have read and agree to the terms and conditions as specified in the National Enviromental Performance Track Program Guide. This facility, to the best of my knowledge, continues to meet all program criteria;
- I have personally examined and am familiar with the information contained in this Annual Performance Report. The information contained in this report is, to the best of my knowledge and based on reasonable inquiry, true, accurate, and complete;
- My facility has an environmental management system (EMS), as defined in the Performance Track EMS criteria, including systems to maintain compliance with all applicable federal, state, tribal, and local environmental requirements, in place at the facility, and the EMS will be maintained for the duration of the facility's participation in the program;
- My facility has conducted an objective assessment of its compliance with all applicable federal, state, tribal, and local environmental requirements; and the facility has corrected all identified instances of potential or actual noncompliance; and
- Based on the foregoing compliance assessments and subsequent corrective actions (if any were necessary), my facility is, to the best of my knowledge and based on reasonable inquiry, currently in compliance with applicable federal, state, tribal, and local environmental requirements.
I agree that EPA's decision whether to accept participants into or remove them from the National Environment Performance Track is wholly discretionary, and I waive any right that may exist under any law to challenge EPA's acceptance or removal decision. I am the senior manager with responsibility for the facility and am fully authorized to execute this statement on behalf of the corporation or other legal entity whose facility is part of the National Environmental Performance Track program.
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| ______________________________________________________ |
| Mr. Krenly Cruz |
| Acting General Manager |
| 787-272-7601 |
| kcruz3@janpr.jnj.com |
| Janssen Ortho LLC |
| Road 933 KM 0.1 Mamey Ward
Gurabo, PR 00778-9629 |
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| A020020 |