TITLE 4. CONSERVATION AND NATURAL RESOURCES
VA.R. Doc. No. R24-7807; Filed March 26, 2024
TITLE 4. CONSERVATION AND NATURAL RESOURCES
VA.R. Doc. No. R24-7808; Filed March 26, 2024
TITLE 4. CONSERVATION AND NATURAL RESOURCES
VA.R. Doc. No. R24-7809; Filed March 26, 2024
TITLE 4. CONSERVATION AND NATURAL RESOURCES
VA.R. Doc. No. R24-7810; Filed March 26, 2024
TITLE 4. CONSERVATION AND NATURAL RESOURCES
VA.R. Doc. No. R24-7806; Filed March 26, 2024
TITLE 9. ENVIRONMENT
TITLE 9. ENVIRONMENT
STATE WATER CONTROL BOARD
Final Regulation
REGISTRAR'S NOTICE: The State Water Control Board is claiming an exemption from the Administrative Process Act in accordance with § 2.2-4006 A 8 of the Code of Virginia, which exempts general permits issued by the State Water Control Board pursuant to the State Water Control Law (§ 62.1-44.2 et seq.) and Chapters 24 (§ 62.1-242 et seq.) and 25 (§ 62.1-254 et seq.) of Title 62.1 of the Code of Virginia if the board (i) provides a Notice of Intended Regulatory Action in conformance with the provisions of § 2.2-4007.01 of the Code of Virginia; (ii) following the passage of 30 days from the publication of the Notice of Intended Regulatory Action, forms a technical advisory committee composed of relevant stakeholders, including potentially affected citizens groups, to assist in the development of the general permit; (iii) provides notice and receives oral and written comment as provided in § 2.2-4007.03 of the Code of Virginia; and (iv) conducts at least one public hearing on the proposed general permit. The State Water Control Board will receive, consider, and respond to petitions by any interested person at any time with respect to reconsideration or revision.
Title of Regulation: 9VAC25-190. Virginia Pollutant Discharge Elimination System (VPDES) General Permit Regulation for Nonmetallic Mineral Mining (amending 9VAC25-190-15, 9VAC25-190-20, 9VAC25-190-50, 9VAC25-190-60, 9VAC25-190-70).
Statutory Authority: § 62.1-44.15 of the Code of Virginia; § 402 of the federal Clean Water Act; 40 CFR Parts 122, 123, and 124.
Effective Date: July 1, 2024.
Agency Contact: Peter Sherman, Department of Environmental Quality, 1111 East Main Street, Suite 1400, P.O. Box 1105, Richmond, VA 23218, telephone (804) 659-2666, FAX (804) 698-4178, or email peter.sherman@deq.virginia.gov.
Background: The Virginia Pollutant Discharge Elimination System (VPDES) General Permit Regulation for Nonmetallic Mineral Mining (9VAC25-190) has existed since 1994. This general permit contains effluent limitations, monitoring requirements, and special conditions for discharges of process wastewater, which may be commingled with stormwater, and stormwater associated with industrial activity to surface waters. The changes to the regulation are being made to reissue this general permit and in response to technical advisory committee suggestions and staff requests to revise, update, and clarify the permit conditions.
Summary:
Amendments to the general permit regulation include (i) revising the term of the general permit regulation to July 1, 2024, through June 30, 2029; (ii) updating the name "Virginia Department of Mines, Minerals and Energy" to "Virginia Department of Energy"; (iii) changing the following aspects of the registration statement requirements: replace facility operator with facility contact; add a National Association of Insurance Commissioners code requirement for permittees; revise the substantially identical and representative stormwater outfall language; add a requirement to indicate ownership type; and add a conditional electronic submittal requirement for registration statements, which provides for notice and a three-month period before it becomes effective; (iv) specifying that for visual monitoring of stormwater discharges, samples must be in a clean, colorless glass or plastic container and examined in a well-lit area; (v) revising the total maximum daily load (TMDL) special condition so it is not limited to stormwater and is consistent with VPDES requirements and other permits; (vi) adding discharge requirements for emergency dewatering during flooded conditions; (vii) revising the representative outfalls provision to coordinate with edits to the registration statement; (viii) under Stormwater Pollution Prevention Plan (SWPPP) deadlines, simplifying the reference to continuing coverage by removing the year of the general permit; (ix) supplementing the language triggering review and amendment of the SWPPP to include any other process, observation, or event results in a determination that modifications to the SWPPP are necessary; (x) for authorized non-stormwater discharges, clarifying that firefighting includes firefighting training activities managed in a manner to avoid an instream impact in accordance with § 9.1-207.1 of the Code of Virginia and that building washdown be managed in a manner to avoid an instream impact; (xi) under standard conditions, adding a conditional electronic submittal requirement for discharge monitoring reports that provides for notice and a three-month period before it becomes effective; (xii) under noncompliance reporting, revising the 24-hour reporting language and updating the link for online reporting; (xiii) specifying that online reporting is required for reporting outside of normal working hours; (xiv) for emergency calls, changing "Virginia Department of Emergency Services" to "Virginia Department of Emergency Management's Emergency Operations Center"; and (xv) for inspection and entry, clarifying that an authorized representative of the director includes an authorized contractor acting as a representative of the administrator.
Changes to the proposed regulation clarify provisions and respond to comments by the U.S. Environmental Protection Agency to improve consistency with federal regulations.
9VAC25-190-15. Applicability of incorporated references based on the dates that they became effective.
Except as noted, when a regulation of the U.S. Environmental Protection Agency set forth in Title 40 of the Code of Federal Regulations is referenced or adopted in this chapter and incorporated by reference that regulation shall be as it exists and has been published as of July 1, 2018 [ 2022 2023 ].
9VAC25-190-20. Purpose; effective date of permit.
A. The purpose of this chapter is to establish General Permit Number VAG84 to regulate [ process ] wastewater and stormwater discharges to surface waters from nonmetallic mineral mines as follows:
1. For active and inactive nonmetallic mineral mining facilities in [ SIC Standard Industrial Classification (SIC) ] Major Group 14, this general permit covers discharges composed entirely of stormwater associated with industrial activity.
2. This general permit authorizes the discharge of process wastewater as well as stormwater associated with industrial activity from active and inactive mineral mines classified under:
a. SIC Code 1411 - NAICS Code 212311,
b. SIC Code 1422 - NAICS Code 212312,
c. SIC Code 1423 - NAICS Code 212313,
d. SIC Code 1429 - NAICS Code 212319,
e. SIC Code 1442 - NAICS Code 212321,
f. SIC Code 1455 - NAICS Code 212324,
g. SIC Code 1459 - NAICS Code 212325, excluding bentonite and magnesite mines,
h. SIC Code 1475 - [ NACIS NAICS ] Code 212392, and
i. SIC Code 1499 - NAICS Code 212399, excluding gypsum, graphite, asbestos, diatomite, jade, novaculite, wollastonite, tripoli or asphaltic mineral mines.
3. Coal mining, metal mining, and oil and gas extraction are not covered by this general permit.
B. This general permit will become effective on July 1, 2019 2024, and will expire June 30, 2024 2029. For any covered owner, this general permit is effective upon compliance with all the provisions of 9VAC25-190-50 and the receipt of this general permit.
9VAC25-190-50. Authorization to discharge.
A. Any owner governed by this general permit is authorized to discharge process wastewater and stormwater as described in 9VAC25-190-20 A 1 and 2 to surface waters of the Commonwealth of Virginia provided that:
1. The owner submits a registration statement in accordance with 9VAC25-190-60, and that registration statement is accepted by the board department;
2. The owner submits the required permit fee;
3. The owner complies with the applicable effluent limitations and other requirements of 9VAC25-190-70;
4. The owner has and maintains during such authorization a mineral mining permit for the operation to be covered by this general permit that has been approved by the Virginia Department of Mines, Minerals and Energy, Division of Mineral Mining (or an associated waivered program, locality, or state agency) under provisions and requirements of Title 45.1 45.2 of the Code of Virginia. Mineral mines located in bordering states with discharges in Virginia shall provide documentation that they have a mining permit from the appropriate state authority. Mineral mines owned and operated by governmental bodies not subject to the provisions and requirements of Title 45.1 45.2 of the Code of Virginia are exempt from this requirement; and
5. The board department has not notified the owner that the discharge is not eligible for coverage in accordance with subsection B of this section.
B. The board department will notify an owner that the discharge is not eligible for coverage under this general permit in the event of any of the following:
1. The owner is required to obtain an individual permit in accordance with 9VAC25-31-170 B 3 of the [ VPDES Virginia Pollutant Discharge Elimination System (VPDES) ] Permit Regulation;
2. The owner is proposing to discharge to state waters specifically named in other board regulations that prohibit such discharges;
3. The discharge violates or would violate the antidegradation policy in the water quality standards at 9VAC25-260-30; or
4. The discharge is not consistent with the assumptions and requirements of an approved [ TMDL total maximum daily load (TMDL) ] .
C. Compliance with this general permit constitutes compliance for purposes of enforcement with §§ 301, 302, 306, 307, 318, 403, and 405(b) 405(a) and (b) of the federal Clean Water Act and the State Water Control Law, with the exceptions stated in 9VAC25-31-60 of the VPDES Permit Regulation. Approval for coverage under this general permit does not relieve any owner of the responsibility to comply with any other applicable federal, state, or local statute, ordinance, or regulation.
D. Continuation of permit coverage.
1. Permit coverage shall expire at the end of the applicable permit term. However, expiring permit coverages are automatically continued if the owner has submitted a complete registration statement at least 60 days prior to the expiration date of the permit, or a later submittal date established by the board department, which cannot extend beyond the expiration date of the permit. The permittee is authorized to continue to discharge until such time as the board department either:
a. Issues coverage to the owner under this general permit; or
b. Notifies the owner that the discharge is not eligible for coverage under this general permit.
2. When the owner that was covered under the expiring or expired general permit has violated or is violating the conditions of that permit, the board department may choose to do any or all of the following:
a. Initiate enforcement action based upon the general permit coverage that has been continued;
b. Issue a notice of intent to deny coverage under the reissued general permit. If the general permit coverage is denied, the owner would then be required to cease the discharges authorized by the continued coverage or be subject to enforcement action for discharging without a permit;
c. Issue an individual permit with appropriate conditions; or
d. Take other actions authorized by the VPDES Permit Regulation (9VAC25-31).
9VAC25-190-60. Registration statement.
A. Any owner seeking coverage under this general permit shall submit a complete VPDES [ general permit registration statement General Permit Registration Statement ] in accordance with this section, which shall serve as a notice of intent for coverage under the VPDES general permit for nonmetallic mineral mining facilities.
1. New facilities. Any owner proposing a discharge shall submit a complete registration statement at least 60 days prior to the date planned for commencement of the discharge or a later submittal date established by the board department.
2. Existing facilities.
a. Any owner covered by an VPDES individual permit that is proposing to be covered by this general permit shall submit a complete registration statement at least 240 days prior to the expiration date of the individual VPDES permit.
b. Any owner that was authorized to discharge under the expiring VPDES general permit for nonmetallic mineral mining and that intends to continue coverage under this general permit shall submit a complete registration statement to the board department at least 60 days prior to the expiration of the existing permit or a later submittal date established by the board department.
B. Late registration statements. Registration statements for existing facilities covered under subdivision A 2 b of this section will be accepted after the expiration date of this permit, but authorization to discharge will not be retroactive.
C. The required registration statement shall contain the following information:
1. Facility owner and operator or other facility contact name, address, email address, and telephone number;
2. Facility name, county, and location;
3. Description of mining activity;
4. Primary and secondary SIC and [ NAIC NAICS ] codes;
5. Discharge information including:
a. A list of outfalls identified by outfall numbers;
b. Characterization of the type of each listed outfall's discharge as either process wastewater, stormwater, or process wastewater commingled with stormwater;
c. Characterization of the source of each listed outfall's discharge as either mine pit dewatering, stormwater associated with industrial activity (see definition in 9VAC25-190-10), stormwater not associated with industrial activity, groundwater infiltration, [ process ] wastewater from vehicle or equipment degreasing activities, vehicle washing and return water from operations where mined material is dredged, mined material washing, noncontact cooling water, miscellaneous plant cleanup wastewater, colocated facility discharges (identify the colocated facility), other discharges not listed here (describe), or any combination of the above items listed in this subdivision c;
d. The receiving stream, including wetlands for each outfall listed;
e. The latitude and longitude for each outfall listed; and
f. Indicate which stormwater outfalls will be representative outfalls that require a single discharge monitoring report (DMR). For stormwater outfalls that are to be represented by other outfall discharges, provide a description of the activities associated with those outfalls and explain why they are substantially the same as the representative outfall to be sampled; could operate as substantially identical or representative outfalls (if any). Provide the following for each:
(1) The locations of the outfalls; and
(2) Why the outfalls are expected to discharge substantially identical effluents including, where available, evaluation of monitoring data;
6. Indicate if the facility has a current VPDES permit and the permit number if it does;
7. Description of [ process ] wastewater treatment, reuse or recycle systems, or both;
8. List of any treatment chemicals added to [ process ] wastewater or stormwater that could be discharged. Include safety data sheets, the maximum proposed dosing rates, and a demonstration that application or use will not result in aquatic toxicity;
9. List of colocated facilities;
10. Indicate if the facility is a hazardous waste treatment, storage, or disposal facility;
11. Schematic drawing showing water flow from source to water-using industrial operations to waste treatment and disposal, and disposal of any solids removed from [ process ] wastewater;
12. Aerial photo or scale map that clearly shows the property boundaries, plant site, drainage areas associated with each outfall, locations of all mine pit dewatering, existing, significant sources of materials exposed to precipitation, stormwater or process wastewater outfalls, and [ the ] receiving streams;
13. Evidence, such as the permit-license to operate a mine page, that the operation to be covered by this general permit has a mining permit that has been approved by the Virginia Department of Mines, Minerals and Energy, Division of Mineral Mining (or associated waivered program) under the provisions and requirements of Title 45.1 45.2 of the Code of Virginia (or appropriate bordering state authorization). Mineral mines owned and operated by governmental bodies not subject to the provisions and requirements of Title 45.1 45.2 of the Code of Virginia are exempt from this requirement;
14. Mining permit number;
15. Whether the permitted facility will discharge to a municipal separate storm sewer system (MS4). If yes, the facility owner shall notify the MS4 owner of the existence of the discharge at the time of registration under this permit and include that notification with the registration statement. The notification shall include the following information: the name of the facility, a contact person and contact information, the location of the discharge, the nature of the discharge, and the facility's VPDES general permit number if assigned by DEQ;
16. Indicate if there are vehicle or equipment degreasing activities performed on site. If yes, indicate if there is any process wastewater generated from these activities;
17. Provide certification that the process wastewater system is designed to operate as "no discharge" if special condition 9VAC25-190-70 Part I B 15 is to apply to the facility. Identify the emergency outfall number;
18. State Corporation Commission entity identification number if the facility is required to obtain an entity identification number by law; and
19. Ownership type, whether located on Indian lands, and existing [ VPA VPDES ] permits; and
20. The following certification:
"I certify under penalty of law that this document and all attachments were prepared under my direction or supervision in accordance with a system designed to assure that qualified personnel properly gather and evaluate the information submitted. Based on my inquiry of the person or persons who manage the system or those persons directly responsible for gathering the information, the information submitted is to the best of my knowledge and belief true, accurate, and complete. I am aware that there are significant penalties for submitting false information including the possibility of fine and imprisonment for knowing violations."
D. The registration statement shall be signed in accordance with 9VAC25-31-110.
E. Where to submit. The registration statement shall be delivered to the department by either postal or electronic mail and shall be submitted to the DEQ regional office serving the area where the industrial facility is located. Following notification from the department of the start date for the required electronic submission of Notice of Intent to Discharge forms (i.e., registration statements), as provided for in 9VAC25-31-1020, such forms submitted after that date shall be electronically submitted to the department in compliance with this section and 9VAC25-31-1020. There shall be at least a three-month notice provided between the notification from the department and the date after which such forms must be submitted electronically.
9VAC25-190-70. General permit.
Any owner whose registration statement is accepted by the board department will receive coverage under the following general permit and shall comply with the requirements in the general permit and be subject to all requirements of 9VAC25-31-190.
General Permit No.: VAG84
Effective date: July 1, 2019 2024
Expiration date: June 30, 2024 2029
GENERAL PERMIT FOR NONMETALLIC MINERAL MINING
AUTHORIZATION TO DISCHARGE UNDER THE VIRGINIA POLLUTANT DISCHARGE ELIMINATION SYSTEM AND THE VIRGINIA STATE WATER CONTROL LAW
In compliance with the provisions of the Clean Water Act, as amended, and pursuant to the State Water Control Law and regulations adopted pursuant to it, owners of nonmetallic mineral mines are authorized to discharge to surface waters within the boundaries of the Commonwealth of Virginia, except those specifically named in board regulations that prohibit such discharges.
The authorized discharge shall be in accordance with the information submitted with the registration statement, this cover page, Part I - Effluent Limitations, Monitoring Requirements, and Special Conditions, Part II - Stormwater Management, and Part III - Conditions Applicable to All VPDES Permits, as set forth in this permit.
Part I
Effluent Limitations, Monitoring Requirements, and Special Conditions
A. Effluent limitations and monitoring requirements.
1. During the period beginning with the permittee's coverage under this general permit and lasting until the permit's expiration date, the permittee is authorized to discharge process wastewater and commingled stormwater associated with industrial activity from outfalls.
Such discharges shall be limited and monitored by the permittee as specified below in [ the following table Table 1 ]:
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[ TABLE 1 ]
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EFFLUENT CHARACTERISTICS
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DISCHARGE LIMITATIONS
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MONITORING REQUIREMENTS
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Monthly Average
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Daily Minimum
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Daily Maximum
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Frequency (1)
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Sample Type
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Flow (MGD)
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NL
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NA
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NL
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1/3 Months
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Estimate
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Total Suspended Solids (mg/l)(2)
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30
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NA
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60
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1/3 Months
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Grab
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pH (standard units)(2)(3)
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NA
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6.0
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9.0
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1/3 Months
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Grab
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NL = No Limitation, monitoring required
NA = Not Applicable
(1)1/3 Months equals the following three-month periods each year of permit coverage: January through March, April through June, July through September, and October through December. Discharge Monitoring Reports (DMRs) of quarterly monitoring shall be submitted to the [ DEQ department's applicable ] regional office no later than the 10th day of April, July, October, and January.
(2)See Special Condition 18 with regard to conditions applicable to emergency dewatering.
(3)Where the Water Quality Standards (9VAC25-260) establish alternate standards for pH, [ those standards the most stringent limits (technology-based or water quality-based) ] shall be the minimum and maximum pH effluent limits.
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2. During the period beginning with the permittee's coverage under the general permit and lasting until the permit's expiration date, the permittee is authorized to discharge stormwater associated with industrial activity that does not combine with other [ process ] wastewaters prior to discharge from outfalls.
a. Such discharges shall be [ limited and ] monitored by the permittee as specified below in [ the following table Table 2 ]:
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[ TABLE 2 ]
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EFFLUENT CHARACTERISTICS
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[ DISCHARGE LIMITATIONS EVALUATION VALUE MONITORING ]
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MONITORING REQUIREMENTS
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Monthly Average
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Daily Minimum
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Daily Maximum
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Frequency (1)
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Sample Type
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Flow (MG)
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NA
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NA
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NL
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1/Year
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Estimate(2)
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Total Suspended Solids (mg/l)
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NA
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NA
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[ NL 100 ] (3)
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1/Year
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Grab
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|
pH (standard units)
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NA
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NL
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NL
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1/Year
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Grab
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NL = No Limitation, monitoring required
NA = Not applicable
(1)Discharge Monitoring Reports (DMRs) of yearly monitoring (January 1 to December 31) shall be submitted to the [ DEQ department's applicable ] regional office no later than the 10th day of January.
(2) Estimate of the total volume of the discharge during the storm event.
(3) Permittees shall review the results of the TSS monitoring required by Part I A 2 a to determine if changes to the [ stormwater pollution prevention plan Stormwater Pollution Prevention Plan ] (SWPPP) may be necessary. If the [ TSS total suspended solids (TSS) ] monitoring results are greater than the evaluation value [ of 100 mg/l, indicated in Table 2 ] then the permittee shall perform a routine facility inspection within five days of becoming aware of the exceedance and maintain documentation as described in Part II H 3 d for that outfall. Any deficiencies noted during the inspection shall be corrected within 60 days of being identified.
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b. The permittee shall conduct calendar quarterly visual monitoring of stormwater discharges associated with [ the ] industrial activity. The monitoring shall include examination of stormwater samples representative of storm event discharges from the facility and observation of color, odor, clarity, floating solids, settled solids, suspended solids, foam, oil sheen, and other obvious indicators of stormwater pollution. Samples will be in a clean, colorless glass or plastic container and examined in a well-lit area. Documentation of visual monitoring of stormwater shall be maintained onsite in the SWPPP and include the examination date and time, examination personnel, outfall location, the nature of the discharge (i.e., runoff or snowmelt), visual quality of the stormwater discharge [ , ] and probable sources of any observed stormwater contamination. Part II A regarding monitoring instructions, Part II B regarding representative outfalls, and Part II C regarding sampling waivers shall apply to the taking of samples for visual monitoring except that the documentation required by these sections shall be retained with the SWPPP rather than submitted to the department. Calendar quarters equal the following three-month periods each year of permit coverage: January through March, April through June, July through September, and October through December.
B. Special conditions.
1. Vehicles and equipment utilized during the industrial activity on a site must be operated and maintained in such a manner as to prevent the potential or actual point source pollution of the surface or groundwaters of the state. Fuels, lubricants, coolants, and hydraulic fluids, or any other petroleum products, shall not be disposed of by discharging on the ground or into surface waters. Spent fluids shall be disposed of in a manner so as not to enter the surface or groundwaters of the state and in accordance with the applicable state and federal disposal regulations. Any spilled fluids shall be cleaned up and disposed of in a manner so as not to allow their entry into the surface or groundwaters of the state.
2. No sewage shall be discharged from this mineral mining activity except under the provisions of another VPDES permit specifically issued for that purpose.
3. There shall be no chemicals added to the discharge, other than those listed on the owner's approved registration statement, unless prior approval of the chemical is granted by the board department.
4. The permittee shall submit a new registration statement if the mining permit approved by the Division of Mineral Mining (or associated waivered program, or bordering state mine authority) is modified or reissued in any way that would affect the outfall location or the characteristics of a discharge covered by this general permit. Government owned and operated mines without mining permits shall submit the registration statement whenever outfall location or characteristics are altered. The new registration statement shall be filed within 30 days of the outfall relocation or change in the characteristics of the discharge.
5. The permittee shall notify the department as soon as they know or have reason to believe:
a. That any activity has occurred or will occur that would result in the discharge, on a routine or frequent basis, of any toxic pollutant that is not limited in this permit, if that discharge will exceed the highest of the following notification levels:
(1) One hundred micrograms per liter (100 μg/l) of the toxic pollutant;
(2) Two hundred micrograms per liter (200 μg/l) for acrolein and acrylonitrile; five hundred micrograms per liter (500 μg/l) for 2,4-dinitrophenol and for 2-methyl-4,6-dinitrophenol; and one milligram per liter (1 mg/l) for antimony;
(3) Five times the maximum concentration value reported for that pollutant in the permit application; or
(4) The level established by the board department.
b. That any activity has occurred or will occur that would result in any discharge, on a nonroutine or infrequent basis, of a toxic pollutant that is not limited in this permit, if that discharge will exceed the highest of the following notification levels:
(1) Five hundred micrograms per liter (500 μg/l) of the toxic pollutant;
(2) One milligram per liter (1 mg/l) for antimony;
(3) Ten times the maximum concentration value reported for that pollutant in the permit application; or
(4) The level established by the board department in accordance with 9VAC25-31-220 F.
6. Any and all product, materials, industrial wastes, or other wastes resulting from the purchase, sale, mining, extraction, transport, preparation, or storage of raw or intermediate materials, final product, by-product, or wastes shall be handled, disposed of, or stored in such a manner and consistent with best management practices, so as not to permit a discharge of such product, materials, industrial wastes, or other wastes to state waters, except as expressly authorized.
7. There shall be no discharge of process wastewater pollutants from colocated asphalt paving materials operations. For the purposes of this special condition, process wastewater pollutants are any pollutants present in water used in asphalt paving materials manufacturing that come into direct contact with any raw materials, intermediate product, by-product, or product related to the asphalt paving materials manufacturing process.
8. Process [ water wastewater ] may be used on site for the purpose of dust suppression. Dust suppression shall be carried out as a best management practice but not as a [ process ] wastewater disposal method provided that ponding or direct runoff from the site does not occur during or immediately following its application. Dust suppression shall not occur during a storm event that results in an actual discharge from the site.
9. Process [ water wastewater ] from mine dewatering may be provided to local property owners for beneficial agricultural use.
10. There shall be no:
a. Discharge of floating solids or visible foam in other than trace amounts from process [ water wastewater ] discharges;
b. Solids deposition to surface water as a result of a discharge associated with industrial activity; or
c. Oil sheen resulting from petroleum products discharged to surface water as a result of the industrial activity.
11. The permittee shall report at least two significant digits for a given parameter. Regardless of the rounding convention used (i.e., five always rounding up or to the nearest even number) by the permittee, the permittee shall use the convention consistently and shall ensure that consulting laboratories employed by the permittee use the same convention.
12. Discharges to waters subject to TMDL wasteload allocations with an approved total maximum daily load (TMDL). Owners of facilities that are a source of the specified pollutant of concern to waters for which where a total maximum daily load (TMDL) wasteload allocation has been approved prior to the term of this permit shall incorporate implement measures and controls into the SWPPP required by Part II that are consistent with the assumptions and requirements of the TMDL. The department will provide written notification to the owner that a facility is subject to the TMDL requirements. If the TMDL establishes a numeric wasteload allocation that applies to discharges from the facility, the owner shall perform any required monitoring for the pollutant of concern in accordance with the monitoring frequencies in Part I A and implement measures necessary to meet that allocation. At permit reissuance, the permittee shall submit a demonstration with the registration statement to show the wasteload allocation is being met.
13. The discharges authorized by this permit shall be controlled as necessary to meet applicable water quality standards.
14. Inactive and unstaffed facilities (including temporarily inactive and unstaffed facilities).
a. A waiver of the process and stormwater monitoring and routine inspections may be exercised by the board department at a facility that is both inactive and unstaffed as long as the facility remains inactive and unstaffed. Such a facility is required to conduct an annual a site inspection in accordance with the requirements in Part II H 3 d. No DMR reports will be required to be submitted when a facility is approved as inactive and unstaffed.
b. An inactive and unstaffed sites waiver request shall be submitted to the board department for approval and shall include the name of the facility; the facility's VPDES general permit registration number; a contact person, phone telephone number, and email address (if available); the reason for the request; and the date the facility became or will become inactive and unstaffed. The waiver request shall be signed and certified in accordance with Part III K. If this waiver is granted, a copy of the request and the board's department's written approval of the waiver shall be maintained with the SWPPP.
c. To reactivate the site the permittee shall notify the department within 30 days or an alternate timeframe if written approval is received in advance from the board department, and all process and stormwater monitoring and routine inspections shall be resumed immediately. This notification must be submitted to the department, signed in accordance with Part III K, and retained on site at the facility covered by this permit in accordance with Part III B.
d. The board department retains the authority to revoke this waiver when it is determined that the discharge causes, has a reasonable potential to cause, or contributes to a water quality standards violation.
15. Process wastewater systems designed to operate as "no discharge" shall have no discharge of [ process ] wastewater or pollutants, except in storm events greater than a 25-year, 24-hour storm event. In the event of such a discharge, the permittee shall report an unusual or extraordinary discharge per Part III H of this permit. No sampling or DMR is required for these discharges as they are considered to be discharging in emergency discharge conditions. These discharges shall not contravene the Water Quality Standards (9VAC25-260), as adopted and amended by the board, or any provision of the State Water Control Law. Any other discharge from this type of system is prohibited, and shall be reported as an unauthorized discharge per Part III G of this permit.
16. Best management practices for blasting. The permittee shall utilize best management practices to ensure that contaminants do not enter surface water as a result of blasting at the site.
17. Notice of termination.
a. The owner may terminate coverage under this general permit by filing a complete notice of termination. The notice of termination may be filed after one or more of the following conditions have been met:
(1) Operations have ceased at the facility and there are no longer discharges of process wastewater or stormwater associated with the industrial activity;
(2) A new owner has assumed responsibility for the facility. A notice of termination does not have to be submitted if a VPDES Change of Ownership Agreement Form has been submitted;
(3) All discharges associated with this facility have been covered by a VPDES individual permit or an alternative VPDES permit; or
(4) Termination of coverage is being requested for another reason, provided the board department agrees that coverage under this general permit is no longer needed.
b. The notice of termination shall contain the following information:
(1) Owner's name, mailing address, telephone number, and email address (if available);
(2) Facility name and location;
(3) VPDES general permit registration number for the facility; and
(4) The basis for submitting the notice of termination, including:
(a) A statement indicating that a new owner has assumed responsibility for the facility;
(b) A statement indicating that operations have ceased at the facility, and there are no longer discharges from the facility;
(c) A statement indicating that all discharges have been covered by a VPDES individual permit; or
(d) A statement indicating that termination of coverage is being requested for another reason (state the reason).
c. The following certification:
"I certify under penalty of law that all [ process ] wastewater and stormwater discharges from the identified facility that are authorized by this VPDES general permit have been eliminated, or covered under a VPDES individual or alternative permit, or that I am no longer the owner of the facility, or permit coverage should be terminated for another reason listed above. I understand that by submitting this notice of termination, that I am no longer authorized to discharge nonmetallic mineral mining [ process ] wastewater or stormwater in accordance with the general permit, and that discharging pollutants to surface waters is unlawful where the discharge is not authorized by a VPDES permit. I also understand that the submittal of this notice of termination does not release an owner from liability for any violations of this permit or the Clean Water Act."
d. The notice of termination shall be submitted to the [ DEQ department's applicable ] regional office serving the area where the facility discharge is located and signed in accordance with Part III K.
18. Discharge requirements for emergency dewatering during flooded conditions. For covered facilities except for those in SIC 1475, the monthly average and daily maximum discharge limitations for [ TSS total suspended solids (TSS) ] in Part I A 1 [ Table 1 ] do not apply to mine pit dewatering discharges resulting from a storm equal to or greater than a 10-year, 24-hour storm event that has caused flood conditions within the mine such that normal operation at the active portion of the mine cannot continue. Rather, the TSS levels in such dewatering discharges shall not exceed a daily maximum of 100 mg/l during emergency dewatering. The operator must conduct such dewatering by pumping from the surface of the flooded area through a filtered mechanism to minimize the discharge of solids. The operator shall notify DEQ of such flooded conditions as an unusual or extraordinary discharge as described in Part III H of the permit. The emergency dewatering TSS limitation remains in effect until operation at the active portion of the mine resumes or the emergency dewatering activity has ceased, whichever occurs first. In no case shall the emergency dewatering TSS limit be applicable for more than 30 days from the beginning of the relevant 10-year, 24-hour storm event, unless otherwise approved by DEQ. The permittee shall take actions to maximize the settling of stormwater prior to and during dewatering. Cationic settling agents shall not be used during dewatering without prior DEQ approval of a demonstration that the use will not result in aquatic toxicity. During emergency dewatering, the permittee shall monitor for TSS daily and notify DEQ of any exceedances. Dewatering discharges shall not contravene the Water Quality Standards (9VAC25-260) or any provision of the State Water Control Law.
Part II
Stormwater Management
A. Monitoring instructions.
1. Collection and analysis of samples. Sampling requirements shall be assessed on an outfall-by-outfall basis. Samples shall be collected and analyzed in accordance with the requirements of Part III A.
2. When and how to sample.
a. In the case of snowmelt or a discharge from a stormwater management structure, a representative sample shall be taken at the time the discharge occurs.
b. For all other types of stormwater discharges, a minimum of one grab sample shall be taken resulting from a storm event that results in a discharge from the site (defined as a "measurable storm event"), [ providing provided ] the interval from the preceding measurable storm event discharge is at least 72 hours. The 72-hour storm interval is waived if the permittee is able to document with the discharge monitoring report (DMR) that less than a 72-hour interval is representative for local storm events during the sampling period. The grab sample shall be taken during the first 30 minutes of the discharge. If it is not practicable to take the sample during the first 30 minutes, the sample may be taken during the first three hours of discharge provided that the permittee explains with the DMR why a grab sample during the first 30 minutes was impracticable and maintains that documentation with the SWPPP.
B. Representative outfalls. If a facility has two or more exclusively stormwater outfalls that discharge substantially identical effluents, based on similarity of industrial activity, significant materials, frequency of discharges, and management practices and activities within the area drained by the outfalls, then the permittee may submit information with the registration statement substantiating the request for only one DMR to be issued for the outfall to be sampled that represents one or more substantially identical outfalls monitor the effluent stormwater of just one of the outfalls and report that the observations also apply to the substantially identical outfall. The permittee shall document representative outfalls in the SWPPP and list on the DMR of the outfall to be sampled all outfall locations that are represented by the discharge. The representative outfall monitoring provisions apply to Part I A 2 a monitoring and quarterly visual monitoring.
The permittee must include the following information in the SWPPP:
1. The locations of the outfalls; and
2. An evaluation, including available monitoring data, indicating why the outfalls are expected to discharge substantially identical effluents.
C. Sampling waivers. When a permittee is unable to conduct quarterly stormwater monitoring required under Part I A 2 b within the specified sampling period due to no measurable storm event discharge or adverse weather conditions, documentation shall be submitted explaining the permittee's inability to conduct the stormwater monitoring. The documentation must include the dates and times that the outfalls were viewed and sampling was attempted. Adverse weather conditions that may prohibit the collection of samples include weather conditions that create dangerous conditions for personnel (such as local flooding, high winds, hurricane, tornadoes, or electrical storms, etc.). Acceptable documentation includes National Climatic Data Center weather station data, local weather station data, facility rainfall logs, and other appropriate supporting data. All documentation shall also be maintained with the SWPPP. This waiver is not applicable to annual monitoring required under Part I A 2 a.
D. Stormwater [ pollution prevention plans (SWPPP) Pollution Prevention Plan (SWPPP) ]. [ An A ] SWPPP shall be developed and implemented for the facility. The plan shall include best management practices (BMPs) that are reasonable, economically practicable, and appropriate [ in light of considering ] current industry practices. The BMPs shall be selected, designed, installed, implemented, and maintained in accordance with good engineering practices to eliminate or reduce the pollutants in all stormwater discharges from the facility. The SWPPP shall also include all control measures necessary for the stormwater discharges to meet applicable water quality standards.
The SWPPP requirements of this general permit may be fulfilled, in part, by incorporating by reference other plans or documents, such as an erosion and sediment control plan, a mine drainage plan as required by the Virginia [ Department of Energy ] Division of Mineral Mining, a [ spill prevention control and countermeasure Spill Prevention Control and Countermeasure ] (SPCC) [ plan Plan ] developed for the facility under § 311 of the federal Clean Water Act, or BMP programs otherwise required for the facility provided that the incorporated plan meets or exceeds the SWPPP requirements of Part II H (contents of SWPPP). All plans incorporated by reference into the SWPPP become enforceable under this permit. If a plan incorporated by reference does not contain all of the required elements of Part II H, the permittee must develop the missing SWPPP elements and include them in the required SWPPP.
E. Deadlines for SWPPP preparation and compliance.
1. Owners of existing facilities that were covered under the 2014 Nonmetallic Mineral Mining General Permit that are continuing coverage under this general permit shall update and implement any revisions to the SWPPP within 60 days of the board department granting coverage under this permit.
2. Owners of new facilities, facilities previously covered by an expiring individual permit, and existing facilities not currently covered by a VPDES permit that elect to be covered under this general permit shall prepare and implement the SWPPP prior to submitting the registration statement.
3. Where the owner of an existing facility that is covered by this permit changes, the new owner of the facility shall update and implement any revisions to the SWPPP within 60 days of ownership change.
4. Upon a showing of good cause, the director may establish a later date in writing for the preparation and compliance with the SWPPP.
F. Signature and SWPPP review.
1. The SWPPP shall be signed in accordance with Part III K (signatory requirements), and be retained on site at the facility covered by this permit in accordance with Part III B (records) of this permit. When there are no on-site buildings or offices in which to store the plan, it shall be kept at the [ nearest ] company office [ nearest to the facility location ].
2. The permittee shall make the SWPPP, routine inspection documentation, or other information available to the department upon request.
3. The director, or an authorized representative, may notify the permittee at any time that the SWPPP, BMPs, or other components of the facility's stormwater program do not meet one or more of the requirements of this part. Such notification shall identify specific provisions of the permit that are not being met and may include required modifications to the stormwater program, additional monitoring requirements, and special reporting requirements. Within 60 days of such notification from the director, or as otherwise provided by the director, or an authorized representative, the permittee shall make the required changes to the plan and shall submit to the department a written certification that the requested changes have been made.
G. Maintaining an updated SWPPP. The permittee shall review and amend the SWPPP as appropriate whenever:
1. There is construction or a change in design, operation, or maintenance that has a significant effect on the discharge or the potential for the discharge of pollutants to surface waters;
2. Routine inspections determine that there are deficiencies in the BMPs;
3. Inspections by local, state, or federal officials determine or any other process, observation, or event results in a determination that modifications to the SWPPP are necessary;
4. There is a spill, leak, or other release at the facility; or
5. There is an unauthorized discharge from the facility; or
6. The department notifies the permittee that a TMDL has been developed and applies to the permitted facility.
SWPPP modifications shall be made within 60 calendar days after discovery, observation, or an event requiring [ an a ] SWPPP modification. Implementation of new or modified BMPs (distinct from regular preventive maintenance of existing BMPs described in Part II H 3 b (preventative maintenance) shall be initiated before the next storm event if possible, but no later than 60 days after discovery, or as otherwise provided or approved by the director. The amount of time taken to modify a BMP or implement additional BMPs shall be documented in the SWPPP.
If the SWPPP modification is based on a release or unauthorized discharge, include a description and date of the release, the circumstances leading to the release, actions taken in response to the release, and measures to prevent the recurrence of such releases. Unauthorized releases and discharges are subject to the reporting requirements of Part III G of this permit.
H. Contents of SWPPP. The SWPPP shall include, at a minimum, the following items:
1. Pollution prevention team. Each plan shall identify the staff individuals by name or title who comprise the facility's stormwater pollution prevention team. The pollution prevention team is responsible for assisting the facility or plant manager in developing, implementing, maintaining, revising, and ensuring compliance with the facility's SWPPP. Specific responsibilities of each staff individual on the team shall be identified and listed.
2. Summary of potential pollutant sources. The SWPPP shall identify where industrial materials or activities at the facility are exposed to stormwater. The description shall include:
a. Site map. The site map shall document:
(1) An outline of the drainage area of each stormwater outfall that are within the facility boundaries, each existing structural control measure to reduce pollutants in stormwater run-off, surface water bodies, locations where materials are exposed to precipitation, locations where major spills or leaks identified under Part II H 2 c (spills and leaks) of this permit have occurred, and the locations of the following activities where such activities are exposed to precipitation: fueling stations, vehicle or equipment degreasing, cleaning areas, loading or unloading, locations used for the treatment, storage [ , ] or disposal of wastes and wastewaters, liquid storage tanks, processing areas, and storage areas. The map must indicate all outfall locations. The types of discharges contained in the drainage areas of the outfalls must be indicated either on the map or in an attached narrative.
(2) For each area of the facility that generates stormwater discharges associated with industrial activity, locations of stormwater conveyances, including ditches, pipes, swales, and inlets, and the directions of stormwater flow and an identification of the types of pollutants that are likely to be present in stormwater discharges associated with industrial activity. Factors to consider include the toxicity of the chemicals; quantity of chemicals used, produced, or discharged; the likelihood of contact with stormwater; and history of significant spills or leaks of toxic or hazardous pollutants. Flows with a potential for causing erosion shall be identified.
b. Inventory of exposed materials. A list of the industrial materials or activities, including material handling equipment or activities, industrial machinery, raw materials, industrial production and processes, intermediate products, by-products, final products, and waste products. Material handling activities include to the storage, loading and unloading, transportation, disposal, or conveyance of any raw material, intermediate product, final product, or waste product.
c. Spills and leaks. A list of significant spills and leaks of toxic or hazardous pollutants that occurred at areas that are exposed to precipitation or that otherwise drain to a stormwater conveyance at the facility after the date of three years prior to the date of coverage under this general permit. Such list shall be updated as appropriate during the term of the permit.
d. Sampling data. A summary of existing stormwater sampling data taken at the facility. The summary shall include, at a minimum, any data collected during the previous three years.
3. Stormwater controls. Control measures shall be implemented for all areas identified in Part II H 2 b (inventory of exposed materials) to prevent or control pollutants in stormwater discharges from the facility. All reasonable steps shall be taken to control or address the quality of discharges from the site that may not originate at the facility. The SWPPP shall describe the type, location, and implementation of all BMPs for each area where industrial materials or activities are exposed to stormwater. The BMPs shall also address the following minimum components, including a schedule for implementing such controls:
a. Good housekeeping. Good housekeeping requires the clean and orderly maintenance of areas that [ may have the potential to ] contribute pollutants to stormwater discharges. The SWPPP shall describe procedures performed to minimize contact of materials with stormwater runoff. Particular attention should be paid to areas where raw materials are stockpiled, material handling areas, storage areas, liquid storage tanks, vehicle fueling and maintenance areas, loading or unloading areas, and vehicle entrance and exits. The permittee shall keep clean all exposed areas of the facility that are potential sources of pollutants in stormwater. The permittee shall sweep or vacuum paved surfaces of the site that are exposed to stormwater at regular intervals or use other equivalent measures to minimize the potential discharge of these materials in stormwater. Indicate in the SWPPP the frequency of sweeping, vacuuming, or other equivalent measures.
b. Preventive maintenance. A preventive maintenance program shall involve regular inspection, testing, maintenance, and repairing of all industrial equipment and systems to avoid breakdowns or failures that could result in leaks, spills, and other releases. All BMPs identified in the SWPPP shall be maintained in effective operating condition. The SWPPP shall include a description of procedures and a regular schedule for preventive maintenance and observation of all BMPs and shall include a description of the back-up practices that are in place should a run-off event occur while a BMP is [ off line offline ] or not operating effectively. The effectiveness of nonstructural BMPs shall also be maintained by appropriate means (e.g., spill response supplies available and personnel trained). If site inspections required by Part II H 3 d (routine facility inspections) identify BMPs that are not operating effectively, repairs or maintenance shall be performed before the next anticipated storm event. If maintenance prior to the next anticipated storm event is not possible, maintenance shall be scheduled and accomplished as soon as practicable. Documentation shall be kept with the SWPPP of maintenance and repairs of BMPs, including the dates of regular maintenance, dates of discovery of areas in need of repair or replacement, dates for repairs, dates that the BMPs returned to full function, and the justification for an extended maintenance or repair schedules. The maintenance program shall require periodic removal of debris from discharge diversions and conveyance systems. Permittees using settling basins to control their effluents must provide maintenance schedules for such basins in the SWPPP.
c. Spill prevention and response procedures. The SWPPP shall describe the procedures that will be followed for preventing and responding to spills and leaks, including barriers between material storage and traffic areas, secondary containment provisions, procedures for material storage and handling, response procedures for notification of appropriate facility personnel, emergency agencies, and regulatory agencies and procedures for stopping, containing, and cleaning up spills. Measures for cleaning up hazardous material spills or leaks shall be consistent with applicable RCRA regulations at 40 CFR Part 264 and 40 CFR Part 265. Employees who may cause, detect, or respond to a spill or leak shall be trained in these procedures and have necessary spill response equipment available. If possible, one of these individuals shall be a member of the pollution prevention team. Contact information for individuals and agencies that must be notified in the event of a spill shall be included in the SWPPP and in other locations where it will be readily available.
d. Routine facility inspections.
(1) Personnel who are familiar with the mining activity, the best management practices, and the SWPPP shall be identified to conduct routine facility inspections. Such inspections must include all areas where industrial materials or activities are exposed to stormwater as identified in Part II H 2 b (inventory of exposed materials), including material storage and handling areas, areas where aggregate is stockpiled outdoors, liquid storage tanks, hoppers or silos, material handling vehicles, equipment, and processing areas; off-site tracking of industrial or waste materials or sediment where vehicles enter or exit the site; vehicle and equipment maintenance areas and cleaning and fueling areas; best management practices; and discharge points.
(2) The inspection frequency shall be specified in the SWPPP based upon a consideration of the level of industrial activity at the facility, but shall be a minimum of quarterly. Inspections of best management practices shall include inspection of stormwater discharge diversions, conveyance systems, sediment control and collection systems, containment structures, vegetation, serrated slopes, and benched slopes to determine their adequacy and effectiveness, the integrity of control structures, if soil erosion has occurred, or if there is evidence of actual or potential discharge of contaminated stormwater.
(3) Site inspection and best management practices inspection results must be documented and maintained on-site with the SWPPP.
(4) A set of tracking or followup procedures shall be used to ensure that appropriate actions are taken in response to the inspections. Such actions must include updating pollution sources, updating pollution prevention measures and controls, and updating the SWPPP as appropriate based on information developed during the inspections.
(5) The requirement for routine facility inspections is waived for facilities that have maintained an active [ VEEP E3/E4 status Virginia Environmental Excellence Program (VEEP) E3 (Exemplary Environmental Enterprise) or E4 (Extraordinary Environmental Enterprise) status ].
e. Employee training. Employee training shall be conducted at least annually at active mining sites and at those temporarily inactive sites that are staffed. Employee training programs shall inform personnel responsible for implementing activities identified in the SWPPP or otherwise responsible for stormwater management at all levels of responsibility of the components and goals of the stormwater pollution prevention plan. Training should address topics such as spill response, good housekeeping, and material management practices. All employee training shall be documented in the SWPPP.
f. Recordkeeping and internal reporting procedures. A description of incidents, such as spills, or other discharges, along with other information describing the quality and quantity of stormwater discharges, shall be included in the SWPPP required under this part. Inspections and maintenance activities shall be documented and records of such activities shall be incorporated into the SWPPP. Ineffective best management practices must be recorded and the date of their corrective action noted in the SWPPP.
g. Sediment and erosion control. The plan shall identify areas that, due to topography, land disturbance (e.g., construction, landscaping, site grading), or other factors, have a potential for soil erosion. The permittee shall identify and implement structural, vegetative, or stabilization BMPs to prevent or control on-site and off-site erosion and sedimentation.
h. Management of runoff. The SWPPP shall describe the stormwater runoff management practices (i.e., permanent structural BMPs) for the facility. These types of BMPs are typically used to divert, infiltrate, reuse, or otherwise reduce pollutants in stormwater discharges from the site. Appropriate measures may include: vegetative swales and practices, reuse of collected stormwater (such as for a process or as an irrigation source), inlet controls (such as oil/water separators), snow management activities, infiltration devices, and wet detention or retention devices.
I. Authorized nonstormwater discharges. The following nonstormwater discharges are authorized by this permit:
1. Discharges from emergency firefighting activities or firefighting training activities managed in a manner to avoid an instream impact in accordance with § 9.1-207.1 of the Code of Virginia;
2. Fire hydrant flushing, managed in a manner to avoid an instream impact;
3. Potable water, including water line flushing, managed in a manner to avoid instream impact;
4. Uncontaminated condensate from air conditioners, coolers, and other compressors and from the outside storage of refrigerated gases or liquids;
5. Irrigation drainage;
6. Landscape watering, provided all pesticides, herbicides, and fertilizers have been applied in accordance with approved labeling;
7. Routine external building washdown that does not use detergents or hazardous cleaning products and is managed in a manner to avoid an instream impact;
8. Pavement wash waters where no detergents or hazardous cleaning products are used and no spills or leaks of toxic or hazardous materials have occurred (unless all spilled material has been removed). Pavement wash waters shall be managed in a manner to avoid instream impacts;
9. Uncontaminated groundwater or spring water;
10. Foundation or footing drains where flows are not contaminated with process materials; and
11. Incidental windblown mist from cooling towers that collects on rooftops or adjacent portions of the facility, but not intentional discharges from the cooling tower (e.g., "piped" cooling tower blowdown or drains).
Part III
Conditions Applicable to All VPDES Permits
A. Monitoring.
1. Samples and measurements taken as required by this permit shall be representative of the monitored activity.
2. Monitoring shall be conducted according to procedures approved under 40 CFR Part 136 or alternative methods approved by the U.S. Environmental Protection Agency, unless other procedures have been specified in this permit.
3. The permittee shall periodically calibrate and perform maintenance procedures on all monitoring and analytical instrumentation at intervals that will ensure accuracy of measurements.
4. Samples taken as required by this permit shall be analyzed in accordance with 1VAC30-45, Certification for Noncommercial Environmental Laboratories, or 1VAC30-46, Accreditation for Commercial Environmental Laboratories.
B. Records.
1. Records of monitoring information shall include:
a. The date, exact place, and time of sampling or measurements;
b. The individuals who performed the sampling or measurements;
c. The dates and times analyses were performed;
d. The individuals who performed the analyses;
e. The analytical techniques or methods used; and
f. The results of such analyses.
2. The permittee shall retain records of all monitoring information, including all calibration and maintenance records and all original strip chart recordings for continuous monitoring instrumentation, copies of all reports required by this permit, and records of all data used to complete the registration statement for this permit, for a period of at least three years from the date of the sample, measurement, report, or request for coverage. This period of retention shall be extended automatically during the course of any unresolved litigation regarding the regulated activity or regarding control standards applicable to the permittee, or as requested by the board department.
C. Reporting monitoring results.
1. The permittee shall submit the results of the monitoring required by this permit not later than the 10th day of the month after monitoring takes place, unless another reporting schedule is specified elsewhere in this permit. Monitoring results shall be submitted to the department's regional office.
2. Monitoring results shall be reported on a discharge monitoring report (DMR) or on forms provided, approved or specified by the department. Following notification from the department of the start date for the required electronic submission of monitoring reports, as provided for in 9VAC25-31-1020, such forms and reports submitted after that date shall be electronically submitted to the department in compliance with this section and 9VAC25-31-1020. There shall be at least a three-month notice provided between the notification from the department and the date after which such forms and reports must be submitted electronically.
3. If the permittee monitors any pollutant specifically addressed by this permit more frequently than required by this permit using test procedures approved under 40 CFR Part 136 or using other test procedures approved by the U.S. Environmental Protection Agency or using procedures specified in this permit, the results of this monitoring shall be included in the calculation and reporting of the data submitted in the DMR or reporting form specified by the department.
4. Calculations for all limitations that require averaging of measurements shall utilize an arithmetic mean unless otherwise specified in this permit.
D. Duty to provide information. The permittee shall furnish to the department, within a reasonable time, any information that the board department may request to determine whether cause exists for terminating coverage under this permit or to determine compliance with this permit. The board department may require the permittee to furnish, upon request, such plans, specifications, and other pertinent information as may be necessary to determine the effect of the wastes from its discharge on the quality of state waters, or such other information as may be necessary to accomplish the purposes of the State Water Control Law. The permittee shall also furnish to the department, upon request, copies of records required to be kept by this permit.
E. Compliance schedule reports. Reports of compliance or noncompliance with, or any progress reports on, interim and final requirements contained in any compliance schedule of this permit shall be submitted no later than 14 days following each schedule date.
F. Unauthorized discharges. Except in compliance with this permit or another permit issued by the board department, it shall be unlawful for any person to:
1. Discharge into state waters sewage, industrial wastes, other wastes, or any noxious or deleterious substances; or
2. Otherwise alter the physical, chemical, or biological properties of such state waters and make them detrimental to the public health, or to animal or aquatic life, or to the use of such waters for domestic or industrial consumption, or for recreation, or for other uses.
G. Reports of unauthorized discharges. Any permittee who that discharges or causes or allows a discharge of sewage, industrial waste, other wastes, or any noxious or deleterious substance into or upon state waters in violation of Part III F (unauthorized discharges); or who discharges or causes or allows a discharge that may reasonably be expected to enter state waters in violation of Part III F shall notify the department of the discharge immediately upon discovery of the discharge, but in no case later than 24 hours after said discovery. A written report of the unauthorized discharge shall be submitted to the department within five days of discovery of the discharge. The written report shall contain:
1. A description of the nature and location of the discharge;
2. The cause of the discharge;
3. The date on which the discharge occurred;
4. The length of time that the discharge continued;
5. The volume of the discharge;
6. If the discharge is continuing, how long it is expected to continue;
7. If the discharge is continuing, what the expected total volume of the discharge will be; and
8. Any steps planned or taken to reduce, eliminate, and prevent a recurrence of the present discharge or any future discharges not authorized by this permit.
Discharges reportable to the department under the immediate reporting requirements of other regulations are exempted from this requirement.
H. Reports of unusual or extraordinary discharges. If any unusual or extraordinary discharge, including a bypass or upset, should occur from a treatment works and the discharge enters or could be expected to enter state waters, the permittee shall promptly notify (see NOTE in Part III I 3), in no case later than 24 hours, the department after the discovery of the discharge. This notification shall provide all available details of the incident, including any adverse effects on aquatic life and the known number of fish killed. The permittee shall reduce the report to writing and shall submit it to the department within five days of discovery of the discharge in accordance with Part III I 2. Unusual and extraordinary discharges include any discharge resulting from:
1. Unusual spillage of materials resulting directly or indirectly from processing operations;
2. Breakdown of processing or accessory equipment;
3. Failure or taking out of service some or all of the treatment works; and
4. Flooding or other acts of nature.
I. Reports of noncompliance.
1. The permittee shall report any noncompliance that may adversely affect state waters or may endanger public health.
a. An oral report shall be provided within 24 hours from the time the permittee becomes aware of the circumstances. The following shall be included as information that shall be reported within 24 hours under this subdivision:
(1) Any unanticipated bypass; and
(2) Any upset that causes a discharge to surface waters.
b. A written report shall be submitted within five days and shall contain:
(1) A description of the noncompliance and its cause;
(2) The period of noncompliance, including exact dates and times, and if the noncompliance has not been corrected, the anticipated time it is expected to continue; and
(3) Steps taken or planned to reduce, eliminate, and prevent reoccurrence of the noncompliance.
The board department may waive the written report on a case-by-case basis for reports of noncompliance under Part III I if the oral report has been received within 24 hours and no adverse impact on state waters has been reported.
2. The permittee shall report all instances of noncompliance not reported under Parts Part III I 1 a or 2 1 b, in writing, at the time the next monitoring reports are submitted. The reports shall contain the information listed in Part III I 2 1 b.
NOTE: 3. The immediate (within 24 hours) reports required in Part III G, H, and I may shall be made to the department's regional office. Reports may be made by telephone or online at http://www.deq.virginia.gov/Programs/PollutionResponsePreparedness/MakingaReport.aspx [ https://www.deq.virginia.gov/get-involved/pollution-response https://www.deq.virginia.gov/our-programs/pollution-response ] (online reporting preferred). For reports outside normal working hours, leave a message and this shall fulfill the immediate reporting requirement the online portal shall be used. For emergencies, call the Virginia Department of Emergency Services maintains a 24-hour telephone service Management's Emergency Operations Center (24-hours) at 1-800-468-8892.
J. Notice of planned changes.
1. The permittee shall give notice to the department as soon as possible of any planned physical alterations or additions to the permitted facility. Notice is required only when:
a. The permittee plans alteration or addition to any building, structure, facility, or installation from which there is or may be a discharge of pollutants, the construction of which commenced:
(1) After promulgation of standards of performance under § 306 of the federal Clean Water Act that are applicable to such source; or
(2) After proposal of standards of performance in accordance with § 306 of the federal Clean Water Act that are applicable to such source, but only if the standards are promulgated in accordance with § 306 within 120 days of their proposal;
b. The alteration or addition could significantly change the nature or increase the quantity of pollutants discharged. This notification applies to pollutants that are subject neither to effluent limitations nor to notification requirements specified elsewhere in this permit; or
c. The alteration or addition results in a significant change in the permittee's sludge use or disposal practices and such alteration, addition, or change may justify the application of permit conditions that are different from or absent in the existing permit, including notification of additional use or disposal sites not reported during the permit registration process or not reported pursuant to an approved land application plan.
2. The permittee shall give advance notice to the department of any planned changes in the permitted facility or activity that may result in noncompliance with permit requirements.
K. Signatory requirements.
1. Registration statement. All registration statements shall be signed as follows:
a. For a corporation: by a responsible corporate officer. For the purposes of this section, a responsible corporate officer means: (i) a president, secretary, treasurer, or vice-president of the corporation in charge of a principal business function, or any other person who performs similar policy-making or decision-making functions for the corporation, or (ii) the manager of one or more manufacturing, production, or operating facilities provided the manager is authorized to make management decisions that govern the operation of the regulated facility, including having the explicit or implicit duty of making capital investment recommendations, and initiating and directing other comprehensive measures to assure ensure long-term environmental compliance with environmental laws and regulations; the manager can ensure that the necessary systems are established or actions taken to gather complete and accurate information for permit registration requirements; and where authority to sign documents has been assigned or delegated to the manager in accordance with corporate procedures;
b. For a partnership or sole proprietorship:, by a general partner or the proprietor, respectively; or
c. For a municipality, state, federal, or other public agency:, by either a principal executive officer or ranking elected official. For purposes of this section, a principal executive officer of a public agency includes: (i) the chief executive officer of the agency or (ii) a senior executive officer having responsibility for the overall operations of a principal geographic unit of the agency.
2. Reports and other information. All reports required by permits, and other information requested by the board, department shall be signed by a person described in Part III K 1 or by a duly authorized representative of that person. A person is a duly authorized representative only if:
a. The authorization is made in writing by a person described in Part III K 1;
b. The authorization specifies either an individual or a position having responsibility for the overall operation of the regulated facility or activity such as the position of plant manager, operator of a well or a well field, superintendent, position of equivalent responsibility, or an individual or position having overall responsibility for environmental matters for the company. A duly authorized representative may thus be either a named individual or any individual occupying a named position; and
c. The written authorization is submitted to the department.
3. Changes to authorization. If an authorization under Part III K 2 is no longer accurate because a different individual or position has responsibility for the overall operation of the facility, a new authorization satisfying the requirements of Part III K 2 shall be submitted to the department prior to or together with any reports or information to be signed by an authorized representative.
4. Certification. Any person signing a document under Part III K 1 or 2 shall make the following certification:
"I certify under penalty of law that this document and all attachments were prepared under my direction or supervision in accordance with a system designed to assure that qualified personnel properly gather and evaluate the information submitted. Based on my inquiry of the person or persons who manage the system, or those persons directly responsible for gathering the information, the information submitted is, to the best of my knowledge and belief, true, accurate, and complete. I am aware that there are significant penalties for submitting false information, including the possibility of fine and imprisonment for knowing violations."
L. Duty to comply. The permittee shall comply with all conditions of this permit. Any permit noncompliance constitutes a violation of the State Water Control Law and the federal Clean Water Act, except that noncompliance with certain provisions of this permit may constitute a violation of the State Water Control Law but not the federal Clean Water Act. Permit noncompliance is grounds for enforcement action, for permit coverage termination, or for denial of permit coverage.
M. Duty to reapply. If the permittee wishes to continue an activity regulated by this permit after the expiration date of this permit, the permittee shall apply for and obtain coverage under a new permit. All permittees with currently effective permit coverage shall submit a new registration statement at least 60 days before the expiration date of the existing permit, unless permission for a later date has been granted by the board department. The board department shall not grant permission for registration statements to be submitted later than the expiration date of the existing permit.
N. Effect of a permit. This permit does not convey any property rights in either real or personal property or any exclusive privileges, nor. This permit does it not authorize any injury to private property or invasion of personal rights or any infringement of federal, state, or local laws or regulations.
O. State law. Nothing in this permit shall be construed to preclude the institution of any legal action under, or relieve the permittee from any responsibilities, liabilities, or penalties established pursuant to, any other state law or regulation or under authority preserved by § 510 of the federal Clean Water Act. Except as provided in permit conditions on "bypass" ( as described in Part III U) and "upset" ( as described in Part III V), nothing in this permit shall be construed to relieve the permittee from civil and criminal penalties for noncompliance.
P. Oil and hazardous substance liability. Nothing in this permit shall be construed to preclude the institution of any legal action or relieve the permittee from any responsibilities, liabilities, or penalties to which the permittee is or may be subject under §§ 62.1-44.34:14 through 62.1-44.34:23 of the State Water Control Law.
Q. Proper operation and maintenance. The permittee shall at all times properly operate and maintain all facilities and systems of treatment and control (and related appurtenances) that are installed or used by the permittee to achieve compliance with the conditions of this permit. Proper operation and maintenance also includes include effective plant performance, adequate funding, adequate staffing, and adequate laboratory and process controls, including appropriate quality assurance procedures. This provision requires the operation of back-up or auxiliary facilities or similar systems that are installed by the permittee only when the operation is necessary to achieve compliance with the conditions of this permit.
R. Disposal of solids or sludges. Solids, sludges, or other pollutants removed in the course of treatment or management of pollutants shall be disposed of in a manner so as to prevent any pollutant from such materials from entering state waters.
S. Duty to mitigate. The permittee shall take all reasonable steps to minimize or prevent any discharge or sludge use or disposal in violation of this permit that has a reasonable likelihood of adversely affecting human health or the environment.
T. Need to halt or reduce activity not a defense. It shall not be a defense for a permittee in an enforcement action that it would have been necessary to halt or reduce the permitted activity in order to maintain compliance with the conditions of this permit.
U. Bypass.
1. "Bypass" means the intentional diversion of waste streams from any portion of a treatment facility. The permittee may allow any bypass to occur that does not cause effluent limitations to be exceeded, but only if it also is for essential maintenance to ensure efficient operation. These bypasses are not subject to the provisions of Parts III U 2 and U 3.
2. Notice.
a. Anticipated bypass. If the permittee knows in advance of the need for a bypass, prior notice shall be submitted if possible at least 10 days before the date of the bypass.
b. Unanticipated bypass. The permittee shall submit notice of an unanticipated bypass as required in Part III I (reports of noncompliance).
3. Prohibition of bypass.
a. Bypass is prohibited, and the board department may take enforcement action against a permittee for bypass, unless:
(1) Bypass was unavoidable to prevent loss of life, personal injury, or severe property damage;
(2) There were no feasible alternatives to the bypass, such as the use of auxiliary treatment facilities, retention of untreated wastes, or maintenance during normal periods of equipment downtime. This condition is not satisfied if adequate back-up equipment should have been installed in the exercise of reasonable engineering judgment to prevent a bypass that occurred during normal periods of equipment downtime or preventive maintenance; and
(3) The permittee submitted notices as required under Part III U 2.
b. The board department may approve an anticipated bypass, after considering its adverse effects, if the board department determines that it will meet the three conditions listed in Part III U 3 a.
V. Upset.
1. An upset constitutes an affirmative defense to an action brought for noncompliance with technology-based permit effluent limitations if the requirements of Part III V 2 are met. A determination made during administrative review of claims that noncompliance was caused by upset, and before an action for noncompliance, is not a final administrative action subject to judicial review.
2. A permittee who wishes to establish the affirmative defense of upset shall demonstrate, through properly signed, contemporaneous operating logs or other relevant evidence that:
a. An upset occurred and that the permittee can identify the cause of the upset;
b. The permitted facility was at the time being properly operated;
c. The permittee submitted notice of the upset as required in Part III I; and
d. The permittee complied with any remedial measures required under Part III S.
3. In any enforcement proceeding, the permittee seeking to establish the occurrence of an upset has the burden of proof.
W. Inspection and entry. The permittee shall allow the director or an authorized representative (including an authorized contractor acting as a representative of the administrator), upon presentation of credentials and other documents as may be required by law, to:
1. Enter upon the permittee's premises where a regulated facility or activity is located or conducted or where records must be kept under the conditions of this permit;
2. Have access to and copy, at reasonable times, any records that must be kept under the conditions of this permit;
3. Inspect at reasonable times any facilities, equipment (including monitoring and control equipment), practices, or operations regulated or required under this permit; and
4. Sample or monitor at reasonable times, for the purposes of ensuring permit compliance or as otherwise authorized by the federal Clean Water Act and the State Water Control Law, any substances or parameters at any location.
For purposes of this section, the time for inspection shall be deemed reasonable during regular business hours and whenever the facility is discharging. Nothing contained herein in this general permit shall make an inspection unreasonable during an emergency.
X. Permit actions. Permit coverage may be terminated for cause. The filing of a request by the permittee for a permit modification, revocation and reissuance, or termination, or a notification of planned changes or anticipated noncompliance does not stay any permit condition.
Y. Transfer of permit coverage.
1. Permit coverage is not transferable to any person except after notice to the department.
2. Coverage under this permit may be automatically transferred to a new permittee if:
a. The current permittee notifies the department at least 30 days in advance of the proposed transfer of the title to the facility or property unless permission for a later date has been granted by the department;
b. The notice includes a written agreement between the existing and new permittees containing a specific date for transfer of permit responsibility, coverage, and liability between them; and
c. The board department does not notify the existing permittee and the proposed new permittee of its intent to deny the permittee coverage under the permit. If this notice is not received, the transfer is effective on the date specified in the agreement mentioned in Part III Y 2 b.
Z. Severability. The provisions of this permit are severable, and if any provision of this permit or the application of any provision of this permit to any circumstance is held invalid, the application of such provision to other circumstances and the remainder of this permit shall not be affected thereby.
VA.R. Doc. No. R22-7006; Filed April 03, 2024
TITLE 9. ENVIRONMENT
VA.R. Doc. No. R24-7571; Filed April 03, 2024
TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING
VA.R. Doc. No. R22-6878; Filed March 29, 2024
TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING
TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING
BOARD OF PHARMACY
Proposed Regulation
Title of Regulation: 18VAC110-21. Regulations Governing the Licensure of Pharmacists and Registration of Pharmacy Technicians (amending 18VAC110-21-46).
Statutory Authority: §§ 54.1-2400 and 54.1-3303.1 of the Code of Virginia.
Public Hearing Information:
May 2, 2024 - 9:06 a.m. - Department of Health Professions, 9960 Mayland Drive, Suite 201, Board Room 2, Henrico, Virginia 23233.
Public Comment Deadline: June 21, 2024.
Agency Contact: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Henrico, VA 23233, telephone (804) 367-4456, FAX (804) 527-4472, or email caroline.juran@dhp.virginia.gov.
Basis: Regulations of the Board of Pharmacy are promulgated under the general authority of § 54.1-2400 of the Code of Virginia. Section 54.1-3303.1 of the Code of Virginia sets forth the ability for pharmacists to initiate treatment for certain diseases and conditions.
Purpose: The purpose of the proposed regulation is to ensure that a pharmacist who initiates treatment for patients follows protocols that would render such treatment to be a low risk for patient harm. The rules establishing treatment protocols, appropriate notification of primary care providers, obtaining patient histories, and providing appropriate counseling of patients are necessary to ensure the health and safety of patients who receive treatment from pharmacists.
Substance: The substantive changes (i) require the pharmacist to have a bona fide pharmacist-patient relationship with the patient with whom the pharmacist initiates treatment; (ii) add nicotine replacement therapy and other tobacco-cessation therapies as drugs and therapies with which a pharmacist can initiate treatment for an adult 18 years of age or older; (iii) add a provision allowing a pharmacist to initiate treatment for patients three years of age and older by administering vaccines included on the Immunization Schedule published by the Centers for Disease Control and Prevention (CDC), vaccines for COVID-19, and tests for COVID-19 and other coronaviruses; (iv) ensure that practitioners will be provided notification of initiation of treatment with a patient even if no method exists to send the notification electronically in a manner compliant with the Health Insurance Portability and Accountability Act (42 USC § 1320d et seq.); and (v) require the treating pharmacist to obtain a patient history and, in the case of administration of vaccines to a minor, provide written notice to the minor's parent or guardian that the minor should visit a pediatrician annually.
Issues: The primary advantage to the public is access to health care for certain diseases and conditions at more locations, including a patient's local pharmacy. There are no disadvantages to the public. No primary advantages or disadvantages to the agency or the Commonwealth exist.
Department of Planning and Budget's Economic Impact Analysis:
The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Code of Virginia and Executive Order 19. The analysis presented represents DPB's best estimate of the potential economic impacts as of the date of this analysis.1
Summary of the Proposed Amendments to Regulation. Among other changes, Chapters 7902 and 791 of the 2022 Acts of Assembly expanded the conditions for which pharmacists can initiate treatment. The Board of Pharmacy (board) therefore proposes to amend the Regulations Governing the Licensure of Pharmacists and Registration of Pharmacy Technicians to conform it with the amendments made by the legislation to the Code of Virginia.
Background. All of the proposed amendments to the regulation are essentially identical to the changes made to the Code of Virginia by the legislation.3 Those amendments include the following:
For persons 18 years of age or older, the list of drugs and devices that a pharmacist may initiate treatment with, dispense, or administer is expanded to include (i) vaccines for COVID-19; and (ii) nicotine replacement and other tobacco-cessation therapies, including controlled substances as defined in the Drug Control Act (§ 54.1-3400 et seq. of the Code of Virginia), together with appropriate patient counseling; and
Both the legislation and the proposed regulation also added that the pharmacist must have a bona fide pharmacist-patient relationship with the person 18 years of age or older. Section 54.1-3303 of the Code of Virginia states that a bona fide practitioner-patient relationship exists "if the practitioner has (i) obtained or caused to be obtained a medical or drug history of the patient; (ii) provided information to the patient about the benefits and risks of the drug being prescribed; (iii) performed or caused to be performed an appropriate examination of the patient, either physically or by the use of instrumentation and diagnostic equipment through which images and medical records may be transmitted electronically; and (iv) initiated additional interventions and follow-up care, if necessary, especially if a prescribed drug may have serious side effects."
In addition, for persons three years of age or older a pharmacist may initiate treatment with, dispense, or administer (i) vaccines included on the Immunization Schedule published by the Centers for Disease Control and Prevention and vaccines for COVID-19; and (ii) tests for COVID-19 and other coronaviruses.
Further, a pharmacist who administers a vaccination to a minor shall provide written notice to the parent or guardian that the minor should visit a pediatrician annually.
For a patient of any age, a pharmacist who initiates treatment with or dispenses or administers a drug or device shall notify the patient's primary health care provider, even if no method exists to send the notification electronically in a manner compliant with the federal Health Insurance Portability and Accountability Act, provided that the patient consents to such notification.
Pharmacists who initiate treatment with, dispense, or administer a drug, device, controlled paraphernalia, or other supplies or equipment shall obtain a history from the patient, including questioning the patient for any known allergies, adverse reactions, contraindications, or health diagnoses or conditions that would be adverse to the initiation of treatment, dispensing, or administration.
Finally, it is established that a pharmacist may initiate treatment with, dispense, or administer drugs, devices, controlled paraphernalia, and other supplies and equipment through telemedicine services, as defined in § 38.2-3418.16 of the Code of Virginia, in compliance with all requirements of § 54.1-3303 of the Code of Virginia and consistent with the applicable standard of care.
Estimated Benefits and Costs. In terms of requirements and opportunities, the proposed amendments to the regulation are essentially identical to the amendments in the legislation. Because the statutory language already requires these changes, amending the regulation would have no impact beyond better informing readers of the regulation of those requirements and opportunities.
Businesses and Other Entities Affected. The 1,756 pharmacies in the Commonwealth and the 16,064 licensed pharmacists in the Commonwealth, as well as patients with whom they initiate treatment, are potentially affected by the legislation.
The Code of Virginia requires DPB to assess whether an adverse impact may result from the proposed regulation.4 An adverse impact is indicated if there is any increase in net cost or reduction in net revenue for any entity, even if the benefits exceed the costs for all entities combined. As the proposed amendments neither increase costs nor reduce net revenue for any entity, no adverse impact is indicated.
Small Businesses5 Affected.6 The proposed amendments do not adversely affect small businesses.
Localities7 Affected.8 The proposed amendments neither disproportionally affect any particular localities nor introduce costs for local governments.
Projected Impact on Employment. The proposed amendments do not affect total employment.
Effects on the Use and Value of Private Property. The proposed amendments do not affect the use and value of private property or real estate development costs.
_____________________________
1Section 2.2-4007.04 of the Code of Virginia requires that such economic impact analyses determine the public benefits and costs of the proposed amendments. Further the analysis should include but not be limited to: (1) the projected number of businesses or other entities to whom the proposed regulatory action would apply, (2) the identity of any localities and types of businesses or other entities particularly affected, (3) the projected number of persons and employment positions to be affected, (4) the projected costs to affected businesses or entities to implement or comply with the regulation, and (5) the impact on the use and value of private property.
2See https://lis.virginia.gov/cgi-bin/legp604.exe?221+sum+SB672.
3There are additional changes in the legislation that are not pertinent to the regulation.
4Pursuant to § 2.2-4007.04 D: In the event this economic impact analysis reveals that the proposed regulation would have an adverse economic impact on businesses or would impose a significant adverse economic impact on a locality, business, or entity particularly affected, the Department of Planning and Budget shall advise the Joint Commission on Administrative Rules, the House Committee on Appropriations, and the Senate Committee on Finance. Statute does not define "adverse impact," state whether only Virginia entities should be considered, nor indicate whether an adverse impact results from regulatory requirements mandated by legislation.
5Pursuant to § 2.2-4007.04, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."
6If the proposed regulatory action may have an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include: (1) an identification and estimate of the number of small businesses subject to the proposed regulation, (2) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the proposed regulation, including the type of professional skills necessary for preparing required reports and other documents, (3) a statement of the probable effect of the proposed regulation on affected small businesses, and (4) a description of any less intrusive or less costly alternative methods of achieving the purpose of the proposed regulation. Additionally, pursuant to § 2.2-4007.1 of the Code of Virginia, if there is a finding that a proposed regulation may have an adverse impact on small business, the Joint Commission on Administrative Rules shall be notified.
7"Locality" can refer to either local governments or the locations in the Commonwealth where the activities relevant to the regulatory change are most likely to occur.
8Section 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.
Agency's Response to Economic Impact Analysis: The Board of Pharmacy concurs with the economic impact analysis prepared by the Department of Planning and Budget.
Summary:
Pursuant to Chapters 790 and 791 of the 2022 Acts of Assembly, the proposed amendments expand the conditions for which a pharmacist can initiate treatment. The proposed amendments (i) require the pharmacist to have a bona fide pharmacist-patient relationship with the patient with whom the pharmacist initiates treatment; (ii) add nicotine replacement therapy and other tobacco-cessation therapies as drugs and therapies with which a pharmacist can initiate treatment for an adult 18 years of age or older; (iii) allow a pharmacist to initiate treatment for patients three years of age and older by administering vaccines included on the Immunization Schedule published by the Centers for Disease Control and Prevention, vaccines for COVID-19, and tests for COVID-19 and other coronaviruses; (iv) require practitioners to provide notification of initiation of treatment with a patient even if no method exists to send the notification electronically in a manner compliant with the Health Insurance Portability and Accountability Act (42 USC § 1320d et seq.); and (v) require the treating pharmacist to obtain a patient history and, in the case of administration of vaccines to a minor, provide the minor's parent or guardian written notice that the minor should visit a pediatrician annually.
18VAC110-21-46. Initiation of treatment by a pharmacist.
A. Pursuant to § 54.1-3303.1 of the Code of Virginia, a pharmacist may initiate treatment with, dispense, or administer the following drugs and devices to persons 18 years of age or older with whom the pharmacist has a bona fide pharmacist-patient relationship:
1. Naloxone or other opioid antagonist, including such controlled paraphernalia as defined in § 54.1-3466 of the Code of Virginia as may be necessary to administer such naloxone or other opioid antagonist;
2. Epinephrine;
3. Injectable or self-administered hormonal contraceptives, provided the patient completes an assessment consistent with the United States Medical Eligibility Criteria for Contraceptive Use;
4. Prenatal vitamins for which a prescription is required;
5. Dietary fluoride supplements, in accordance with recommendations of the American Dental Association for prescribing of such supplements for persons whose drinking water has a fluoride content below the concentration recommended by the U.S. Department of Health and Human Services;
6. Drugs and devices as defined in § 54.1-3401 of the Code of Virginia, controlled paraphernalia as defined in § 54.1-3466 of the Code of Virginia, and other supplies and equipment available over the counter covered by the patient's health carrier when the patient's out-of-pocket cost is lower than the out-of-pocket cost to purchase an over-the-counter equivalent of the same drug, device, controlled paraphernalia, or other supplies or equipment;
7. Vaccines included on the Immunization Schedule published by the Centers for Disease Control and Prevention or that have a current emergency use authorization from the U.S. Food and Drug Administration and vaccines for COVID-19;
8. Tuberculin purified protein derivative for tuberculosis testing; and
9. Controlled substances for the prevention of human immunodeficiency virus, including controlled substances prescribed for pre-exposure and post-exposure prophylaxis pursuant to guidelines and recommendations of the Centers for Disease Control and Prevention;
10. Nicotine replacement and other tobacco-cessation therapies, including controlled substances as defined in the Drug Control Act (§ 54.1-3400 et seq. of the Code of Virginia), together with appropriate patient counseling; and
11. Tests for COVID-19 and other coronaviruses.
B. Notwithstanding the provisions of § 54.1-3303 of the Code of Virginia, a pharmacist may initiate treatment with, dispense, or administer the following drugs and devices to persons three years of age or older:
1. Vaccines included on the Immunization Schedule published by the Centers for Disease Control and Prevention and vaccines for COVID-19; and
2. Tests for COVID-19 and other coronaviruses.
The provisions of this subsection will become effective upon expiration of the provisions of the federal Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 related to the vaccination and COVID-19 testing of minors.
C. Pharmacists who initiate treatment with, dispense, or administer a drug or, device, controlled paraphernalia, or other supplies or equipment pursuant to subsection subsections A and B of this section shall:
1. Follow the statewide protocol adopted by the board for each drug, device, controlled paraphernalia, or other supplies or equipment.
2. Notify the patient's primary health care provider that treatment has been initiated with such drug, device, controlled paraphernalia, or other supplies or equipment or that such drug, device, controlled paraphernalia, or other supplies or equipment have been dispensed or administered to the patient, provided that the patient consents to such notification. No pharmacist shall limit the ability of notification to be sent to the patient's primary care provider by requiring use of email that is secure or compliant with the federal Health Insurance Portability and Accountability Act (42 USC § 1320d et seq.) (HIPAA). If the patient does not have a primary health care provider, the pharmacist shall counsel the patient regarding the benefits of establishing a relationship with a primary health care provider and, upon request, provide information regarding primary health care providers, including federally qualified health centers, free clinics, or local health departments serving the area in which the patient is located. If the pharmacist is initiating treatment with, dispensing, or administering injectable or self-administered hormonal contraceptives, the pharmacist shall counsel the patient regarding seeking preventative care, including (i) routine well-woman visits, (ii) testing for sexually transmitted infections, and (iii) pap smears. If the pharmacist is administering a vaccine pursuant to this section, the pharmacist shall report such administration to the Virginia Immunization Information System in accordance with the requirements of § 32.1-46.01 of the Code of Virginia.
3. Maintain a patient record for a minimum of six years following the last patient encounter with the following exceptions:
a. Records that have previously been transferred to another practitioner or health care provider or provided to the patient or the patient's personal representative; or
b. Records that are required by contractual obligation or federal law to be maintained for a longer period of time.
4. Perform the activities in a manner that protects patient confidentiality and complies with the Health Insurance Portability and Accountability Act, 42 USC § 1320d et seq HIPAA.
5. Obtain a history from the patient, including questioning the patient for any known allergies, adverse reactions, contraindications, or health diagnoses or conditions that would be adverse to the initiation of treatment, dispensing, or administration.
6. If administering a vaccination to a minor pursuant to subdivision B 1 of this section, provide written notice to the minor's parent or guardian that the minor should visit a pediatrician annually.
D. A pharmacist may initiate treatment with, dispense, or administer drugs, devices, controlled paraphernalia, and other supplies and equipment pursuant to this section through telemedicine services, as defined in § 38.2-3418.16 of the Code of Virginia, in compliance with all requirements of § 54.1-3303 of the Code of Virginia and consistent with the applicable standard of care.
VA.R. Doc. No. R23-7339; Filed April 02, 2024
TITLE 22. SOCIAL SERVICES
VA.R. Doc. No. R23-7198; Filed March 26, 2024