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Merck, Sharp & Dohme Quimica de Puerto Rico Limited

Other (Former) Names of Site: Merck, Sharp & Dohme Quimica de Puerto Rico, Inc.

PRD090028101
Location:
State Road # 2, Km 56.7, Barceloneta, Puerto Rico 00617

Site Map

EPA Contact:
Angel Salgado, (787) 977-5854,  salgado.angel@epa.gov
Last Updated:
September 2007
Human Exposures Under Control [PDF 239.5 KB, 18 pp] has been verified.
Groundwater Contamination Under Control [PDF 193.64 KB, 11 pp] has been verified.

Site Description

The Merck, Sharp & Dohme Química de Puerto Rico Ltd (MSDQ) facility is located at Road #2 km. 56.7, in the Municipality of Barceloneta, Puerto Rico. The facility is located approximately three miles south of the Atlantic Ocean and 38 miles due west of San Juan. The site is bordered by industries to the north and west, and “mogotes” (undeveloped large, round hills with steep sides formed by erosion of natural limestone) surround the remainder of the property.

MSDQ is a wholly-owned subsidiary of Merck and Company, Inc. and has existed at this location since 1971 as an operating pharmaceutical manufacturing plant. The facility currently manufactures human and animal health products such as anti-hypertensives, beta-blockers, diuretics, and anti-parasitic drugs.

As a result of these manufacturing processes, the facility generates hazardous wastes, including chlorinated and non-chlorinated solvents, solid and sludge wastes, and residues from waste incineration operations. MSDQ has been authorized to manage hazardous wastes under a Resource Conservation and Recovery Act (RCRA) permit since November 1988. 

Site Responsibility

MSDQ operates under a RCRA Permit issued by EPA; the site’s Corrective Action activities are overseen primarily by EPA. However, the Puerto Rico Environmental Quality Board (EQB) participates with EPA, and provides technical support and assistance, regarding permitting and corrective action activities.

Threats and Contaminants

Pharmaceutical operations at this site began in 1971, when regulations for the management of hazardous wastes were not as effective as they are today. As part of its manufacturing operations, MSDQ has generated hazardous wastes such as chlorinated and non-chlorinated solvents, solid and sludge wastes containing heavy metals, and residues from waste incineration.

The assessments conducted under the RCRA Corrective Action Program at this site identified toluene contamination in soils as the main potential environmental threat. Soils contaminated with toluene at the Old Landfill, specifically, have been found to exceed EPA’s health-based criteria. This former industrial and sanitary waste landfill was in service from 1971 to 1981. EPA is currently evaluating the options to address this contamination under the Corrective Action scheme.

Corrective Action Status

Only one solid waste management unit (SWMU), the Old Landfill, remains under RCRA Corrective Action at the MSDQ facility in Barceloneta. Of thirty-seven SWMUs originally assessed in the 1986 RCRA Facility Assessment (RFA), only five showed low levels of soil contamination: the Old Landfill, the Secure Landfill, the Equalization Basin, the Wastewater Treatment Plant (WWTP) Degritter/Skimmer, and Tank 5311. These five SWMUs were further assessed in 1989 under a RCRA Facility Investigation (RFI). The RFI Report (March 1990) concluded that only the Old Landfill showed toluene contamination in soils that exceeded the established health-based criteria. The remaining four SWMUs were dropped from further consideration.

A Preliminary Corrective Measures Feasibility Study (CMS) Report was submitted to EPA on December 1990. The CMS evaluated several remedial alternatives for addressing toluene contamination in soils at the Old Landfill. At the time, the CMS determined that in-situ soil venting was the most suitable remedial alternative. In 2001, MSDQ went a step further and submitted a Sampling and Analysis Plan (SAP) to Investigate Intrinsic Biodegradation at the Old Landfill, which deviated from the remedial option selected in the CMS.

A revised Sampling and Analysis Plan (SAP) was submitted to EPA in September 2003 to investigate bioremediation as remedial alternative; the field work related to this SAP was completed in October 2003. Field work results from the SAP implementation were submitted to EPA in a document titled “Final Corrective Measures Implementation at the Old Landfill” (CMI Report) dated October 2004. The report provided a characterization of the extent of toluene contamination in soils and the unsaturated zone under the Old Landfill; it also attempted to prove that natural attenuation/biodegradation was indeed occurring. The report concluded that favorable geological conditions (such as the presence of low permeability clays and the depth of the groundwater), the absence of exposure pathways, and the absence of toluene detections in groundwater, all granted no further remedial actions at the Old Landfill.

After reviewing the Corrective Measures Implementation (CMI) Report, EPA provided technical comments to MSDQ, indicating essentially that the data provided was insufficient to demonstrate the occurrence of biodegradation MSDQ responded EPA’s comments in November 2006, and EPA is discussing these comments with facility representatives MSDQ has submitted a document titled “Remedial Performance Soil Sampling and Analysis Plan for Intrinsic Biodegradation at the Old Landfill” for EPA’s review.

Permit Status

MSDQ renewed its RCRA Hazardous Waste Management Permit in August 2006; the permit is effective for ten years. Hazardous waste activities at MSDQ have been authorized since November 1988, when the first RCRA permit was issued by EPA. The permit currently authorizes MSDQ to manage two hazardous waste container storage areas, seven aboveground hazardous waste storage tanks, and two hazardous waste incinerators. The emissions of the incinerators are currently regulated under both RCRA and Clean Air Act (CAA) permits.

Site Repository

Copies of technical documents and correspondence regarding RCRA permit and corrective action activities at the MSDQ-Barceloneta facility are available for public review at the following locations:

USEPA-Caribbean Environmental Protection Division
1492 Ponce de Leon Ave., Stop 22
Centro Europa Bldg., Suite 417
Santurce, Puerto Rico   00907-4127
Phone (787) 977-5865

U.S. Environmental Protection Agency, Region 2
RCRA Records Center
290 Broadway, 15th Floor, Room 1538                                             
New York, New York 10007-1866
Phone (212) 637-3043

The inspection of some of the documents cited in the site fact sheet may require a formal request under the United States Freedom of Information Act (FOIA).

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