1. Modification for Microbiology Laboratory Instructions doc format of Modification for Microbiology Laboratory Instructions
pdf format of Modification of Certification for Microbiology Lab

  2. Modification of Certification for Microbiology Laboratory doc format of Modification of Certification for Microbiology Lab
pdf format of Modification of Certification for Microbiology Lab

  3. Transmittal Form & Number for Permit Application & Payment


Permit Fact Sheet

1. What is the purpose of this permit?
Application to certify additional testing category(s) at microbiological analysis laboratories as authorized
pursuant to MGL c. 21, s.27, c. 21A, s. 2(28), c 21C, s. 4, c. 21E, s. 3, c. 111 § 142A-142E, 150A, 160 and
310 CMR 42.00
These regulations establish a program for Department certification of laboratories to conduct analytical
measurements for purposes of determining compliance with Department standards where the Department or
a client requires that such measurements be conducted by a certified laboratory.
A program for the certification of laboratories conducting analytical measurements of drinking water is
necessary for Massachusetts to meet the requirements of primary enforcement responsibility under the Safe
Drinking Water Act and the National Primary Drinking Water Regulations. Massachusetts also certifies
laboratories analyzing non-potable water. The Laboratory Certification Program identifies laboratories capable
of consistently producing valid data (although certification does not guarantee the validity of the data).


2. Who must apply for this permit?
Any person (private corporation, individual, partnership or association, or other entity) who intends to conduct
analytical measurements for the purposes of determining compliance with Department standards where the
Department or the laboratory’s client requires such measurements be conducted by a certified laboratory.


3. What other requirements should be considered when applying for this permit?
a. What prerequisites should be considered before applying for this permit?
None
b. What additional technical information must be provided to apply for this permit?
• Results of Proficiency Tests (PTs) performed by the laboratory must be submitted by the laboratory’s
PT Provider in accordance with the current Wall Experiment Station PT Policy.
• Laboratory Quality Assurance Plan.
• A laboratory located out-of-state seeking certification under 310 CMR 42.16 must submit a copy of
the certificate and certified parameter list issued by its resident state or the USEPA and a copy of the
on-site inspection report written by the certifying authority of the laboratory’s resident state or the
USEPA.


4. How should one apply for the permit?
To apply for any permit covered by 310 CMR 4.00, MassDEP's Timely Action and Fee Provisions, an
applicant must complete, sign and submit:
1. a MassDEP Transmittal Form for Permit Application and Payment
http://mass.gov/dep/service/online/trasmfrm.shtml, and
2. a MassDEP application form for the appropriate permit category.
The Transmittal form is a unique numbered form which must be submitted with each application package.
Transmittal Form must be submitted as follows:
• One copy accompanies the permit application sent to the MassDEP Primary Permitting Location
indicated below.
• One copy accompanies payment to the MassDEP Post Office Box as indicated in Question 6 below.
• One copy for the applicant's records
All additional information, as defined in Question 3b above and identified in the Application Completeness
checklist included in this application package, must be submitted with a copy of the transmittal form for the
application to be processed properly.
PRIMARY PERMIT LOCATION
Director, Laboratory Approval Program
Massachusetts Department of Environmental Protection
Wall Experiment Station
37 Shattuck Street
Lawrence, MA 01843


5. What is the fee for this permit?
The fees for this permit are listed in the LES04 application. A complete list of fees for all laboratory
certification categories may be found at Permit Application Timelines and Fees Schedule pdf format of Permit Application Timelines and Fees Schedule


6. How and when do I pay?
Payment should be made only by check payable to the: Commonwealth of Massachusetts. One copy of the
transmittal form http://mass.gov/dep/service/online/trasmfrm.shtml must accompany the check and be
forwarded to the following address:
Massachusetts Department of Environmental Protection
P.O. Box 4062
Boston, MA 02211
Pursuant to 310 CMR 4.02 the following entities are exempt from these fees: any city, town, county, or district
of the Commonwealth or any municipal housing authority. Applications for permits made by another state
agency which cost $100 or less are exempt from payment.


7. When will I get the permit?
If your application is administratively complete when first submitted, and if the information you provide is
technically sufficient, MassDEP must provide a decision on the permit by the end of the timelines for the
administrative review, the technical review, inspection review and any public comment review that may be
required. MassDEP must refund the fee if it cannot issue its decision within the required time period.
It is in the best interest of the applicant to submit a complete, thorough and accurate application. If the
application has administrative deficiencies or technical deficiencies, a second review period will be required
for each, thereby extending the timeframe for a final decision on the permit application. Further information on
timelines is presented in questions 8, 9 and 10.


8. When does the timeline begin?
The timeline begins on the day following the receipt of the application and payment. The schedule for timely
action will be suspended if there is a failure of payment for any reason following the recording date. MassDEP
will inform you of the timelines and the name and telephone number of the individual handling the application.


9. What are the timelines for permit review?
Schedules for timely action vary for each permit, but all will include some combination of the following review
periods:
Administrative Completeness Review (AC) - to determine whether all required elements of the application
have been provided by the applicant. The Department may request additional information during the review.
An initial administrative completeness review will result in:
• a determination of administrative completeness, or
• a statement of administrative deficiencies
If necessary, a second administrative completeness review will be conducted. After the applicant responds to
the statement of deficiencies, the second AC review period will be the same number of days allowed in the
first AC review period. The result of the second review will be:
• a determination of administrative completeness, or
• a denial of the permit application
Technical Review (T1) - to review the merits of the permit application and supporting materials. More
information may be requested without stopping the clock during a technical review. The result of an initial
technical review is:
• a decision to grant or deny the permit, or
• a statement identifying technical or other substantive deficiencies in the application process.
• a decision to conduct an on-site inspection of the laboratory
An applicant may decline to provide additional information in response to a statement of technical deficiency
and obtain a decision by MassDEP based on the record at the time. If this option is chosen, there will be no
supplemental technical review.
Note: A failure to respond to a statement of technical deficiency within the time allowed by the Department will
result in a permit denial with no refund.
Supplemental Technical Review (T2) - to review the merits of the permit application and supporting
materials as supplemented, modified, or amended as a result of a deficiency in T1. A supplemental technical
review may be required if MassDEP would otherwise deny or substantially modify or restrict the certificate
based on the available information. Additional information may be requested during the review, but the clock
will not stop. A supplemental technical review will result in:
• a decision to grant or deny the permit, or
• an on-site inspection
On-Site Inspection and Post Inspection Review - to conduct an on-site inspection of the facilities to
determine whether the laboratory satisfies the Department's standards for certification. An on-site laboratory
inspection and post inspection review will result in:
• a statement identifying deficiencies, if any, identified during the on-site or post inspection review, and
• a decision to grant or deny the permit
Supplemental Inspection Review - to review the merits of the on-site inspection and supporting materials as
supplemented, modified, or amended. Additional information may be requested during the review, but the
clock will not stop. A supplemental inspection review will result in:
• a decision to grant or deny the permit
NOTE: A decision to grant or deny a permit following the inspection review period is subject to appeal.
The timelines for this permit are available on the MassDEP Website: Permit Application Timelines and Fees Schedule pdf format of Permit Application Timelines and Fees Schedule


10. What if MassDEP does not complete its work before the expiration of the timeline?
Generally, if the review of the application package is not completed according to the scheduled timelines,
MassDEP will refund the fee to the party who paid the original fee. This does not determine that a permit will
be denied or approved. Approval does not depend on adherence to the timelines by MassDEP, nor is a permit
considered to be granted if the timelines are not met. This refund system is intended to demonstrate the good
faith efforts of MassDEP to increase efficiency while continuing to protect the environment.
Be advised that the timelines may be affected by provisions in the regulations including but not limited to
failure of payment, other agency actions and judicial and enforcement proceedings. Please refer to the
regulations for more detail.


11. What if my application is withdrawn?
If an applicant withdraws an application before the beginning of the technical review, 50% of the fee will be
refunded. If the applicant withdraws at any time after the technical review begins, none of the fee will be
refunded.


12. What is the purpose of the annual compliance/assurance fee for this permit?
Compliance assurance fees are designed to provide adequate resources for enforcement, inspection and
monitoring programs. These resources are essential to the improvement and effective maintenance of these
programs. Without assured compliance, some members of the regulated community will continue to violate
environmental laws and regulations, while honest members will be placed at a competitive disadvantage.
Generally, no annual compliance/assurance fee shall be assessed for a permit in the fiscal year in which the
permit is issued. Please consult 310 CMR 4.03 of the fees regulations for further information.


13. How much will I pay for the annual compliance/assurance fee?
A complete list of fees for all laboratory certification categories may be found at Permit Application Timelines and Fees Schedule pdf format of Permit Application Timelines and Fees Schedule


14. How long is the permit in effect?
According to 310 CMR 42.09 (2), certificates shall be valid for one year unless earlier revoked in accordance
with 310 CMR 42.12.


15. What can I do to avoid the most common mistakes made in applying for this permit?
• Make sure the application form is completed with all requested information especially with regard to
personnel qualifications.
• Submit all requested materials including the laboratory quality assurance plan
• Keep all application materials up to date by notifying the MassDEP of any change in the application
including any changes in personnel. Submit new Proficiency Test Study results as they become
available. Laboratories located outside Massachusetts should provide copies of updated certificates
and certified parameter lists issued by the laboratory’s resident state or the USEPA.


16. Where can I get copies of the regulations that apply to this permit?
These regulations include, but are not limited to:
• The Certification and Operation of Environmental Analysis Laboratories contained in 310 CMR 42.00.
• The Timely Action and Fee Provisions, 310 CMR 4.00.
• The Administrative Penalty Regulations, 310 CMR 5.00.
These may be purchased online, in person, or by Mail at the Massachusetts State Bookstore

 

 

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Permit Application Timelines and Fees Schedule pdf format of Permit Application Timelines and Fees Schedule

These may be purchased online, in person, or by Mail at the Massachusetts State Bookstore