Medizone Intl. (fka MZEIQ)

[Tane61]

The U.S. EPA and OZONE

The EPA has been apprised of the potential risks surrounding the use of OZONE in a healthcare setting.

The EPA has revised the data requirements for antimicrobial PESTICIDE PRODUCTS to protect, in part, HUMAN HEALTH.

The FDA has taken a position on the generation of OZONE within the healthcare setting.

Medizone parks # three(3) ozone destruct unit OUTSIDE space (sealed) to be treated?

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January 28, 2011

Joan Harrigan-Farrelly
Director
Antimicrobial Division
Office of Pesticide Programs
U.S Environment Protection Agency

Dear Ms. Harrigan-Farrelly:

On behalf of the Association for Professionals in Infection Prevention (APIC), the Society for Healthcare Epidemiology of America (SHEA) and the Association for the Healthcare Environment (AHE) formerly ASHES, we welcome the opportunity to comment on the topic of fogging applications for disinfectants. The issues are very pertinent to our organizations and we are responding collectively to reinforce our close agreement on mutual concerns, especially worker safety.....When used properly, HP also likely offers a greater margin of safety compared to other chemicals that can also be applied by vapor such as chlorine dioxide or ozone.(Davies A, 2011, in press JHI)

7. Are there any active ingredients that may be problematic for your facility as foggers?

Ingredients that affect OSHA exposure limits that may affect workers, especially agents such as formaldehyde or phenol-based agents, would be a concern. The latter were chemicals that stimulated investigation and ultimately specific recommendations against their use by CDC. Other chemicals such as chlorine dioxide and ozone also have many documented safety issues that would preclude their use in healthcare facilities.(Davies,JHI2011)

http://www.shea-online.org/Portals/0/SHEA-APIC-AHE_EPA_fogging_letter_FINAL_%28012811%29.pdf

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Data Requirements for Antimicrobial Pesticides

http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2008-0110-0111


Action

Final rule.

Summary

EPA is revising the data requirements for antimicrobial pesticide products to reflect current scientific and regulatory practice, and to provide the regulated community with clearer and transparent information about the data needed to support pesticide registration decisions for antimicrobial products. The updated data requirements also serve to further enhance EPA's ability to make regulatory decisions about the human health, and environmental fate and effects of antimicrobial pesticide products. These revisions are also expected to help protect human health and the environment by providing an up-to-date scientific framework for identifying and assessing the risks of antimicrobial pesticides sold or distributed in the United States.

Dates

This final rule is effective July 8, 2013.


Supplementary Information

I. Executive Summary

A. Does this action apply to me?

You may be affected by this action if you are a producer of pesticide products (NAICS 32532), antifoulants (NAICS 32551), antimicrobial pesticides (NAICS 32561) or wood preservatives (NAICS 32519), importers of such products, or any person or company who seeks to register an antimicrobial, antifoulant coating, ballast water treatment, or wood preservative pesticide or to obtain a tolerance for such a pesticide. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed could also be affected.

B. What is the agency's authority for taking this action?

This action is issued under the authority of sections 2, 3, 4, 5, 10, 12, and 25 of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq., and section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. The data required for antimicrobials (e.g., for registration, reregistration or registration review, experimental use permit (EUP), or tolerance/tolerance exemption) are currently listed in 40 CFR part 161 and, with this final rule, will be listed in 40 CFR part 158.

C. What action is the agency taking?

The Agency is revising and updating the data requirements for antimicrobial pesticides that are currently found in Title 40 of the Code of Federal Regulations (CFR) in part 161, and which are being relocated as revised by this rule to subpart W of part 158. Subpart W sets out data requirements specific to antimicrobial products that are described by the antimicrobial use patterns and use exposure considerations particular to antimicrobials. With the promulgation of part 158, subpart W, EPA is removing part 161, entitled “Data Requirements for Registration of Antimicrobial Pesticides” as it is no longer needed.

Antimicrobial pesticides are used to control microbiological contamination in healthcare applications, and deterioration in industrial, commercial, and consumer products. Nearly 60 percent of antimicrobial products are registered as public health products (as defined at FIFRA 2(gg)) to control infectious microorganisms in hospitals and other health care environments. Public health products are intended to control microorganisms infectious to humans in any inanimate environment. The common public health antimicrobial products include sterilants, disinfectants, and sanitizers. Nonpublic health products are sold and distributed for use to control growth of algae, odor-causing bacteria, bacteria which cause spoilage, deterioration or fouling of materials and microorganisms infectious only to animals. Other examples of nonpublic health products include products used in cooling towers, jet fuel, paints, and treatments for textile and paper products. Within this final rule EPA is using the term antimicrobials to collectively refer to antimicrobial pesticides, antifoulant coatings and paints, and wood preservatives. The amendments contained in this final rule, which are discussed in detail in Units IV. through XXII. of this document, change the existing data requirements for antimicrobial pesticides in the following substantive respects:

By changing some of the existing data requirements, such as a change from conditionally-required to required, a change in the number of test species, or expanding the number of use patterns for which the test is required.

By adding newly codified data requirements, i.e., data requirements that are not currently identified in 40 CFR part 161, but are considered in current practice on a case-by-case basis.

By adding new data requirements, i.e., data requirements that have not been required or have rarely been required in current practice on a case-by-case basis, and have not been routinely considered during the Agency's evaluation of the data needed for the purpose of risk assessment.

By eliminating the requirement for the chronic non-rodent study currently required in 40 CFR part 161.

By codifying the antimicrobial data requirements as finalized in this rule in 40 CFR part 158, subpart W, and removing the current requirements that appear in 40 CFR part 161.

D. What are the incremental costs and benefits of this action?

The Economic Analysis (EA) of the potential costs and benefits associated with this action, as revised to address comments received on the proposed rule, is contained in a document entitled “Final Economic Analysis of Changes in Data Requirements for Antimicrobial Pesticides” (Ref. 1), a copy of which is in the docket, discussed in Unit XXII., and are briefly summarized here.

1. Estimated costs. In its analysis, the Agency considered the potential, additional costs for the registration of new antimicrobial pesticides or new uses of currently registered antimicrobial pesticides, as well as the potential, additional costs incurred during the registration review of existing antimicrobial pesticides.

The estimated total annual industry costs of the final rule is expected to be about $19.3 million. The difference between the baseline costs (the existing data requirements that were codified in 1984) and the cost of the Agency's current practices is about $1 million annually. The difference between the baseline costs and the final rule costs, i.e., the incremental costs, is approximately $8.2 million annually assuming an estimated 15 new registrations.

Under the final rule, the average cost per registration action of a new antimicrobial active ingredient is approximately $1 million to $5 million. For existing chemicals, data requirements in part 158, subpart W are relevant to the registration review program, and the average additional cost is estimated to be about $588,000 for wood preservatives, $284,000 for food and indirect food uses, and $260,000 for all other uses. For registration review, the total annual cost is $6.8 million.

EPA also conducted an analysis of the potential impact of this final rule on small entities, which is included in the EA and discussed in Unit XXV.C. In brief, EPA estimates that 500, or approximately 67 percent, of the unique parent companies that constitute the total universe of pesticide antimicrobial registrants, qualify as a small business. When considering both registration review and new registrations, on average each year about 30 small businesses are estimated to incur additional costs under this final rule. EPA estimates that about 23 small firms (almost 5 percent of the 500 small antimicrobial firms) may experience an economic impact of 3 percent or more of gross sales. As discussed later in this document, EPA has concluded, based on this analysis, that this potential impact is not a significant impact on a substantial number of small entities.

2. Estimated benefits. In its analysis, EPA provides a qualitative discussion of the benefits, which are not quantifiable in the same monetary terms as the costs. In general, before manufacturers can sell pesticides in the United States, EPA must evaluate the pesticides thoroughly to ensure that they meet Federal safety standards in FIFRA and FFDCA that were established to protect human health and the environment. EPA grants a “registration” or license that permits a pesticide's distribution, sale, and use only after the company meets the scientific and regulatory requirements. In evaluating a pesticide registration application, EPA assesses a wide variety of potential human health and environmental effects associated with use of the product. Applicants, or potential registrants, must generate or provide the scientific data necessary to address the identity, composition, potential adverse effects, and environmental fate of each pesticide. The information provided by the data requirements in this final rule allow EPA to evaluate whether an antimicrobial pesticide meets the applicable statutory standards.

Antimicrobials play an important role in public health and safety. While intended to provide health benefits of pathogen control or removal and, in some cases, safety benefits of materials preservation, they also involve risks of potential efficacy failure and exposure of hazards to humans and the environment. Therefore, the effectiveness and proper use of an antimicrobial pesticide is determined by EPA based on its evaluation of specific data that is provided as part of registration and registration review activities.

This final rule will enhance EPA's ability to make sound regulatory decisions and help prevent the registration of pesticide products that may have unreasonable adverse effects on human health and the environment. The Agency believes that having the appropriate data ultimately leads to better risk management decisions, as well as provides the following other benefits: ......

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[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2012]

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 801 -- LABELING

Subpart H--Special Requirements for Specific Devices
Sec. 801.415 Maximum acceptable level of ozone.

(a) Ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy. In order for ozone to be effective as a germicide, it must be present in a concentration far greater than that which can be safely tolerated by man and animals.

(b) Although undesirable physiological effects on the central nervous system, heart, and vision have been reported, the predominant physiological effect of ozone is primary irritation of the mucous membranes. Inhalation of ozone can cause sufficient irritation to the lungs to result in pulmonary edema. The onset of pulmonary edema is usually delayed for some hours after exposure; thus, symptomatic response is not a reliable warning of exposure to toxic concentrations of ozone. Since olfactory fatigue develops readily, the odor of ozone is not a reliable index of atmospheric ozone concentration.

(c) A number of devices currently on the market generate ozone by design or as a byproduct. Since exposure to ozone above a certain concentration can be injurious to health, any such device will be considered adulterated and/or misbranded within the meaning of sections 501 and 502 of the act if it is used or intended for use under the following conditions:

(1) In such a manner that it generates ozone at a level in excess of 0.05 part per million by volume of air circulating through the device or causes an accumulation of ozone in excess of 0.05 part per million by volume of air (when measured under standard conditions at 25 deg. C (77 deg. F) and 760 millimeters of mercury) in the atmosphere of enclosed space intended to be occupied by people for extended periods of time, e.g., houses, apartments, hospitals, and offices. This applies to any such device, whether portable or permanent or part of any system, which generates ozone by design or as an inadvertent or incidental product.

(2) To generate ozone and release it into the atmosphere in hospitals or other establishments occupied by the ill or infirm.

(3) To generate ozone and release it into the atmosphere and does not indicate in its labeling the maximum acceptable concentration of ozone which may be generated (not to exceed 0.05 part per million by volume of air circulating through the device) as established herein and the smallest area in which such device can be used so as not to produce an ozone accumulation in excess of 0.05 part per million.

(4) In any medical condition for which there is no proof of safety and effectiveness.

(5) To generate ozone at a level less than 0.05 part per million by volume of air circulating through the device and it is labeled for use as a germicide or deodorizer.

(d) This section does not affect the present threshold limit value of 0.10 part per million (0.2 milligram per cubic meter) of ozone exposure for an 8-hour-day exposure of industrial workers as recommended by the American Conference of Governmental Industrial Hygienists.

(e) The method and apparatus specified in 40 CFR part 50, or any other equally sensitive and accurate method, may be employed in measuring ozone pursuant to this section.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=801.415

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MEDIZONE INTERNATIONAL, INC. FORM 10-Q

We believe that many of the risks previously discussed in our SEC filings are part of doing business in the industry in which we operate and will likely be present in all periods reported. The fact that certain risks are endemic to the industry does not lessen their significance. The forward-looking statements contained in this report are made as of the date of this report and we assume no obligation to update them or to update the reasons why actual results could differ from those projected in such forward-looking statements. Among others, risks and uncertainties that may affect our business, financial condition, performance, development, and results of operations include:

· Rigorous government scrutiny and regulation of our products and planned products;

· Potential effects of adverse publicity regarding ozone and related technologies or industries;

· Failure to sustain or manage growth including the failure to continue to develop new products; and

· The ability to obtain needed financing.

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Chairman’s Message – September 2012
"NOTE: AsepticSure may now be used for investigational purposes in the United States, allowing that final FDA and EPA approvals are required prior to sales in the US market."

"Final regulatory approvals for the US market by both the FDA and EPA should be achieved not later than January 2013"