QUESTIONS AND ANSWERS MONITORING WAIVERS (Re: SOURCE WATER QUALITY)
QUESTIONS AND ANSWERS MONITORING WAIVERS (Re: SOURCE WATER QUALITY)
The Department of Health Services’ Food and Drug Branch (FDB) has sent a notice (dated August 14, 2001) to all licensed firms announcing that beginning January 2002 FDB will offer an optional benefit by issuing waivers to private water source operators (for in-state sources) and out-of-state bottlers (for out-of-state sources) regarding the required annual chemical analysis of source water.
In the notice, FDB stated: (1) the Title 21, Code of Federal Regulations, Section 129.35(a)(4)(ii), which California adopts, allows a firm to reduce the frequency of testing of its source as well as the number of chemical contaminants for which it tests the source water if it can document that such reduction is consistent with a State-issued waiver under EPA regulations; (2) the monitoring waivers will be granted on a firm-by-firm and contaminant-by-contaminant basis, and also be based on the vulnerability assessment for the particular contaminant(s) and the previous analytical results; (3) the waivers will be effective for three years from the date of issuance and may be renewed; and (4) an applicant requesting a waiver must submit a request in writing and provide supporting information.
The following “Questions/Answers” were prepared to guide applicants. They are intended only to be guidance, and so, do not bind FDB. Nor do they create or confer any rights, privileges, or benefits for or on any person.
Question 1: For which types of contaminants will FDB likely grant waivers?
Answer: FDB expects that waivers will be given mostly for inorganic chemicals and non-volatile synthetic organic chemicals such as pesticides, polychlorinated biphenyls, dioxin. It may not issue waivers for volatile organic chemicals (VOC’s) because VOC’s are ubiquitous in California and other states, and their analyses are relatively inexpensive.
Question 2: What are the criteria for granting a monitoring waiver for a contaminant?
Answer: The waiver will be granted based on: 1) sufficient information for favorable vulnerability assessment, and 2) several years of sampling/test results (at least three continuous years of annual sampling including that of the immediate past year) showing that the contaminant was reliably and consistently below its allowable level.
NOTE: FDB will consider both the “no detection” and “within the allowable limit” test results for waivers in two tier approaches:
Tier 1: If not detected for at least 3 consecutive years using the FDA approved method (see 21CFR 165.110 (b) for the list of methods to be used) at a certified laboratory, no other supporting information for the vulnerability assessment for the particular contaminant will be necessary (Please refer to Question 4 for the format for submitting data);
Tier 2: If detected but less than the allowable level in any of the three or more consecutive year period, the applicant must provide supporting information (see Question 3 for the list of supporting information to be submitted).
Question 3: Can you identify the types of supporting information that will be necessary for the vulnerability assessment?
Answer: The vulnerability will be based on a determination that either (1) the contaminant has not been used, manufactured, transported, stored and disposed of within the watershed or zone of influence (generally, about 2 miles is a sufficient radius around the source, depending on hydrogeological conditions); or (2) the source water is not susceptible to contamination.Supporting information (documents) includes, but not limited to:
- Statement by the applicant whether the contaminant has been used, manufactured, stored, transported, or disposed of in the area. If yes, explain the facts in detail.
- Disclose the extent of search for the statement (e.g., list of references: names and phone numbers of the governmental agencies that were contacted, and copies of relevant documents if available). The agencies that may have the information include: Regional Water Quality Control Board, County Agricultural Commissioner’s Office, Public or Municipal Drinking Water District, CAL-EPA (Integrated Waste Management Control Board), Department of Transportation, US Department of Agriculture, Soil Conservation Services, US EPA.
- Statement whether a waiver for the contaminant(s) was issued to a nearby public or municipal drinking water well (if yes, provide a copy of the waiver if available; identify the name of the water district that issued the waiver, the location of the well and its distance to the applicant’s source).
- Copies of the sampling and test results including a table (Please see Question 4 for details)
Question 4: What is the format for submitting the previous sampling/test results (at least three continuous years of annual sampling including that of the immediate past year)?
Answer: FDB suggests that: (1) a table summarizing the data be developed: showing, in each column or row, the name of contaminant(s), sampling date(s), test date(s), method(s) used, analytical variation(s), and detection limit(s); and (2) the raw data (copies of the actual reports received from the laboratory) be attached. If the copies of the data have previously been submitted to FDB as part of the licensure, the applicant may not need to attach the copies but must identify the date(s) of data submission, sampling date(s), the name(s) of the testing laboratory(s), and laboratory certification number(s)/state. Providing the table is not mandatory, but will significantly expedite our review process for approving the request.
Question 5: Would licensed private water source operators and out-of-state water bottlers still need to submit the annual analysis for source water for substances that were not waived?
Answer: Yes. All substances that were not waived must be sampled and tested annually pursuant to 21CFR 129.35(a)(3), and a copy of the test results must be submitted to FDB as part of licensure. FDB requests that the annual test results be submitted together with a photocopy of the waiver (Note: the waiver will list the name(s) of substance(s) that was waived and its expiration date).
Question 6: What test methods must be used for the analysis?
Answer: All testing must be done by the test methods listed in 21CFR 165.110(b) and by a laboratory(s) approved by the California Department of Health Services (i.e., California Environmental Laboratory Accreditation Program), the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency (EPA), the primary enforcement authority in states which have been granted primacy by the U.S. EPA or by a third-party organization acceptable to a primary state.
Question 7: How long will the waiver be effective?
Answer: It will be effective for 3 years from the date of issuance, and may be renewed.
Question 8: Will bottlers be required to perform analysis for any of the waived parameters after the initial 3 year period in order to substantiate an extension for another 3 year period?
Answer: The request for an extension will be treated like the first time application for monitoring waivers and handled on a case by case basis. Not all applicants will be required to perform the analysis for any of the waived parameters for the extension. However, some reasonable suspicion that any of the substances may threaten the public health will trigger the requirement to perform the analysis (including but not limited to: complaints received; relevant issues raised by the media and the public; safety concerns raised by our field offices and other agencies; new construction, drilling or other modifications that were made to the water extraction, delivery and storage system; reported storms, flooding or earthquakes.).
Question 9: Will the waiver also be applicable to the required annual testing of product water (i.e., bottled water or vended water)?
Answer: No. The waiver will be applicable only to source water testing. Product waters must be tested for ALL substances in accordance with 21CFR 129.80(g).
Question 10: Will the waiver be applicable to bottlers that distribute products in states other than California?
Answer: No. The waiver will be applicable only to the source water which is used for bottling products that are to be distributed in California. Bottlers, that distribute products to a state other than California, may be required to perform some or all of the analyses for the other state, even if they receive a waiver from California.
Question 11: Can you summarize the overall protocol for submitting the request for a waiver?
Answer: The request for a waiver must include:
- A formal request (a signed letter) identifying: firm name and address; name, phone number and e-mail address (if available) of the contact person, license number [the private water source operator license number for an in-state (California) source and out-of-bottling plant license number for an out-of-state source]; location of the source; type of water from the source; list of contaminants that are requested for the waiver.
- The previous sampling/test results and other supporting information (a table summarizing the data, the raw data and information for vulnerability assessment; please see “Question 4” for details. Also, refer to “Questions 2 and 3” for the types of supporting information).
Question 12: Where can I send the request for a waiver?
Answer: Please send your request to:
California Department of Health Services
Food and Drug Branch (Attention: Water Licensing Desk)
601 North 7th Street (MS 357)
P.O. Box 942732
Sacramento, CA 94234-7320
If you still have questions or should require further guidance, please feel free to contact FDB Licensing Desk at (916) 323-4774.