01/24/2024
They had some JCARR reviews and this is what I sent to them and ODA. They went to at least 2 more sections where they put in the "including" language besides the original. Less regulation they have in mind, I think not.
Again, all sections with "including processors of intoxicating beverages" are not supported in any of the Ohio Revised Code for OAC regulations as Food Processors. This language should be eliminated and possibly replaced with some language as I suggested previously to maintain FDA contracts.
For this section OAC 901:3-18-01, and all other OAC sections that mention Intoxicating beverages, put in some language like... "including processors of intoxicating beverages registered with the FDA for contract inspections only" ...could be used?
I mentioned this way below and it would only be for those contract inspections of businesses that are larger that meet the definition of who is subject to the inspections for the bioterrorism act. Basically, if they are registered with the FDA and sell wholesale in dollars more than they retail they would meet the FDA definition, not using the Ohio definition, which is irrelevant to the FDA. This way you are proxy for them and not licensing and regulating contrary to what the ORC really says. Also, still getting the contract money.
Below are previous sections I sent and response to a previous business impact analysis that applies.
ORC 4301.01 B (8)-
"Manufacture" includes all processes by which beer or intoxicating liquor is produced, whether by distillation, rectifying, fortifying, blending, fermentation, or brewing, or in any other manner.
*This section of ORC does mention "produced" and says "all processes".
ORC 4301.10
(A) The division of liquor control shall do all of the following:
(1) Control the traffic in beer and intoxicating liquor in this state, including the manufacture, importation, and sale of beer and intoxicating liquor;
The Food defense program against intentional adulteration is an FDA rule for alcoholic beverages not an Ohio one. The ORC does not give authorization to ODA to do this. I also question The unelected bureaucrats in the FDA rule, but have not delved into the FAA act and other. My concern is Ohio agencies overreach.
ORC3715.02(A) The director of agriculture shall adopt rules in accordance with Chapter 119. of the Revised Code that establish, when otherwise not established by a law of this state, definitions for a food or class of food and standards for the following items as they pertain to the food or class of food:
ORC3715.021(B) The director of agriculture shall adopt rules in accordance with Chapter 119. of the Revised Code that establish, when otherwise not established by the Revised Code, standards and good manufacturing practices for food processing establishments, including the facilities of food processing establishments and their sanitation
Standards are otherwise established by another law of the state or the Revised Code and also in Federal and state liquor codes, as well as sanitation and a boatload of regulations for processing. You have basically taken authority that is not given in the ORC. Your food processing regulations violate my principles of enhancing microbial diversity in my winemaking environment. Wine kills human pathogens and not sustainable in beer neither so your GMP's are mostly irrelevant for wine or beer production and are a hazard to innovative concepts of enhancing a wineries microbiome. With my principles of winemaking it is impossible for me to be subject to your "real food" based regulations and be able to wholesale again.
ORC4301.01
(A) As used in the Revised Code:
(1) "Intoxicating liquor" and "liquor" include all liquids and compounds, other than beer, containing one-half of one per cent or more of alcohol by volume which are fit to use for beverage purposes, from whatever source and by whatever process produced, by whatever name called, and whether they are medicated, proprietary, or patented. "Intoxicating liquor" and "liquor" include cider and alcohol, and all solids and confections which contain one-half of one per cent or more of alcohol by volume.
*FDA has authority for wine or non beer under 7 %, Ohio ORC does not give ODA any authority for that neither. Note the use of process and produced in this section also.
A B2A permit issued by Div of Liquor Control is to wholesale. Your permit at ODA is to sell wholesale. That is a duplication of licensing. Which wineries in other states are not equivalently subject to an ODA or similar permit. You are discriminating against our wineries in favor of out of state ones. The same goes for the authority for regulations that have a business cost (or suppression in your case). In 901:3-21-01 the ORC exception does not give authority to duplicate license and collect fees for wholesaling or other. Maybe and exception should be put in "not including processors of intoxicating beverages".
The food code in ORC does have the exception listed as found elsewhere in Ohio law or the Revised Code. Mentioning the first part of the section for all your support and ignoring the rest is ridiculous reasoning.
The language of this needs to be changed to eliminate the "including processors of intoxicating beverages".
You claim CFR language that does not apply to anyone that sells more retail than they do wholesale. It extends Ohio regulation that goes well beyond Federal law requirements in (21 C.F.R. Chapter 1, Subchapter B, Part 121). Making extra burden on businesses with exemption from Federal law. Both sections as listed below make exception to what is "otherwise established by law or Revised code". It tells you there is exception to what ODA claims, their simplistic response as told before many times is absurd. Dispense with the lies and do what is right according to the ORC. The liquor codes in ORC 43 give complete authority to "only" the Div of Liquor Control for licensing and processing. The definitions, standards of identity, classes of alcoholic beverages are all in Liquor codes "not" food codes.
-In one of the CSI Business Impact Analysis that was posted for 901:17. the one for 901:18 was similar.
1. R.C. 106.03 and 106.031 require agencies, when reviewing a rule, to determine whether the rule has an adverse impact on businesses as defined by R.C. 107.52. If the agency determines that it does, it must complete a business impact analysis and submit the rule for CSI review. Which adverse impact(s) to businesses has the agency determined the rule(s) create?
*These were not checked and I've lost well in to 6 figures of income to hold my principles of winemaking that ODA sems to want to destroy.
a. ☐ Requires a license, permit, or any other prior authorization to engage in or operate a line of business.
*They do have fee based registration (license) permit for all businesses after they get started. Not calling it what it is, is dishonest. Also, could not find any list of license holders registered with the ODA as food processors. Seems like subterfuge of some sort.
d. ☐ Is likely to directly reduce the revenue or increase the expenses of the lines of business to which it will apply or applies
Yes, I have lost revenue and business growth to keep from being submitted to this abomination. I will not compromise my winemaking to ignorance and lose all that I value. More than about money when artistic principles are at risk.
3. Please list the Ohio statute(s) that authorize the agency, board or commission to adopt the rule(s) and the statute(s) that amplify that authority. ORC 3715.02, 3715.021
*As noted both of these have the exception for "otherwise in law or the ORC". ORC/OAC 43 have all that applies to make the exception and more authority than the federal government due to its 21st amendment, You are violating the laws of use therein, which are in ORC 43. Which makes for an equal protection issue. Out of state wineries do not necessarily have any food processing regulation to follow and they do sell in Ohio under a B2A permit, same as the one I have that I cannot use. The discrimination against our own businesses is quite apparent.
4. Does the regulation implement a federal requirement? Is the proposed regulation being adopted or amended to enable the state to obtain or maintain approval to administer and enforce a federal law or to participate in a federal program? If yes, please briefly explain the source and substance of the federal requirement. Yes, these rules are federal requirements for all applicable food processing establishments.
*"Wrong the federal requirements are irrelevant to wineries selling more retail than wholesale as they are exempt. This regulation does not stipulate for FDA inspections only, it includes others.
5. If the regulation implements a federal requirement, but includes provisions not specifically required by the federal government, please explain the rationale for exceeding the federal requirement. Not applicable.
*Yes, it is applicable see #4 . They certainly do exceed the federal requirements.
6.What is the public purpose for this regulation (i.e., why does the Agency feel that there needs to be any regulation in this area at all)? The Ohio Department of Agriculture is tasked with ensuring that all food products manufactured in the state of Ohio are produced and stored in a safe, sanitary establishment. Without these regulations food could be produced or stored in a facility that is filthy, unclean, with a high potential of food borne illnesses
*The regulations go well beyond what is needed for Alcohol processors. There is essentially "NO" risk of human pathogens. Wine outright kills them at a disinfectant level. The regulations are BS. The duplicate licensing fee to support something we have no contribution to the problem is not rational. As mentioned elsewhere all processes, storage, distribution and sales for intoxicating beverages are regulated by ORC 43 and subsequent regulations in the OAC. The exception is listed in both of the supporting ORC sections for this regulation .
*Read the ORC, they are clearly not in compliance with the validity and legality of their inspections. Duplication is part of the issue, there is code for less severe processing regulations in ORC/OAC43. I'm not sure the FDA has authority they have excessively intruded with the Bio Terrorism Act Registrations for traceability by adding what most consider nonsense for wineries and breweries. For the FDA and ODA it's a matter of "2 wrongs never make a right" when intruding on alcoholic beverage producers and laws!
11. What scientific data was used to develop the rule or the measurable outcomes of the rule? How does this data support the regulation being proposed? The rules contained in the package mirror standards that are nationally accepted. The rules were developed over years of research by the FDA utilizing the industry and other public entities. The rules present the best approach to address protecting the food supply from intentional adulteration.
* There is a lot of science that supports the non-inclusion of processors or intoxicating beverages. California, Oregon, and Washington states all exempt outright breweries and wineries from being licensed and regulated as Food Processors. Ohio does too... if you have any reading comprehension, just more of a roundabout way.
12. What alternative regulations (or specific provisions within the regulation) did the Agency consider, and why did it determine that these alternatives were not appropriate? If none, why didn’t the Agency consider regulatory alternatives? Alternative regulations may include performance-based regulations, which define the required outcome, but do not dictate the process the regulated stakeholders must use to comply.
The department is statutorily tasked with developing and establishing standards for this industry. The standards that are contained in this rule are based on scientific research and are in line with the federal regulations. Lack of stakeholder participation in this rule package has indicated to the Department that this is the best regulatory scheme at this time as it allows Ohio manufacturers to ship their products across the country. For those reasons, no other regulatory alternatives were considered.
* The federal rules do not apply to small wineries and breweries. Also, I think this is a dishonest way of trying to reduce the "number" of regulations by referring to the CFR. There is no real reduction of regulations to meet the intent of the legislation to reduce the number of regulations. This rule goes beyond the FDA rules in the CFR. Many other states do not regulate wineries and breweries as Food Processors. Many stakeholders have no concern for very small businesses, there is always crony capitalism at issue. Some larger wineries in Ohio produce bottled grape juice in their wineries and wish to maintain a good crony relationship with the ODA as they are given permission in liquor codes to produce the food products and see no reason to oppose the regulations imposed on smaller wineries. It is in essence anti-competitive against smaller wineries and likely some breweries. The science does not support this for wineries and breweries, except those who actually produce a "real food" product like juice.
13. What measures did the Agency take to ensure that this regulation does not duplicate an existing Ohio regulation?
The Department has sole regulatory authority among Ohio agencies and acts as the in-state inspector for the FDA.
* Absolutely not! ORC and OAC 43 via Div of Liquor Control has sole regulatory authority of producers of intoxicating beverages. Yes, it is duplicated in violation of their own codes which have the exceptions in them. FDA is irrelevant to regulations that also are the Ohio regulations. The including processors of intoxicating beverages needs to be qualified for only FDA inspections, not all inspections are legal for them to perform under ORC. A license to wholesale by both ODA and Div of Liquor Control is nonsense.
Adverse Impact to Business
15. Provide a summary of the estimated cost of compliance with the rule(s). Specifically, please do the following:
a. Identify the scope of the impacted business community, and This covers all qualified food processing establishments in Ohio. All food manufacturers operating within the state of Ohio, except for those specifically exempted in the rules.
*Illegally Impacting processors of intoxicating beverages which are "specifically included" when they should be excluded for Ohio regulations. Qualified in Ohio is different than qualifed under FDA. Never with no problems before 2010. I have lost 6 figures of income to maintain my principles of winemaking which are not compatible with food regulations that suppress microbial diversity and my old world winemaking methods. We import millions of bottle of wine made in that manner with no problems. I've been open 26 years and have made wine since 1981 with no problems of any food safety issues. These regulations are wrong, wrong and more wrong.
b. Quantify and identify the nature of all adverse impact (e.g., fees, fines, employer time for compliance, etc.). The adverse impact can be quantified in terms of dollars, hours to comply, or other factors; and may be estimated for the entire regulated population or for a representative business. Please include the source for your information/estimated impact.
There are many factors to determine the cost of complying with this regulation. Each firm must develop a plan that fits their operation. They will need to develop the plan and monitor and record findings. There are no fines associated with this regulation.
However, failure to comply with the requirements may result in adulteration and eventual embargo or destruction of products.
*ODA has no authority for any of this and all that is under ORC 43. We answer to the TTB with much more restrictive list of additives and other than the FDA, as well as to the Div of Liquor Control.
16. Are there any proposed changes to the rules that will reduce a regulatory burden imposed on the business community? Please identify. (Reductions in regulatory burden may include streamlining reporting processes, simplifying rules to improve readability, eliminating requirements, reducing compliance time or fees, or other related factors).
NO!
*This is in reality an increase of regulatory burden over what is in CFR. Very small exemption to FDA inspections is wholesaling less in dollars than retail. Very small to ODA is no wholesaling at all. Certain types of food have exemption, but none of them have a food safety type record of less problems than intoxicating beverages. The regulatory burden should be to remove the "including processors of intoxicating beverages" from the regulation. I have lost much from this ridiculous illegal overregulation. I do not believe they have authority to do the contract FDA inspections on processors of intoxicating beverages. Maybe some disclaimer that says "for FDA contract inspections of processors of intoxicating beverages wholesaling in dollars more than retail only" would pass muster. You would then be complying with the CFR code as it is written.
17. Why did the Agency determine that the regulatory intent justifies the adverse impact to the regulated business community?
The prevention of food borne illnesses and the protection of consumers is outweighed by the adverse impact of these regulations. The regulatory intent of these rules is considered justified due to the public safety risk.
*With wineries and breweries the risk is extremely minimal. Food borne illnesses issue is nonexistent. Wine kills human pathogens and not sustainable in beer neither. As well ORC gives all authority to Division of Liquor Control for alcohol manufacturing, distribution and sales. FDA should not be involved neither, and is not with wineries that retail more than they wholesale in dollars. Why is Ohio ODA exceeding what the FDA and CFR state when it is not even supported in Ohio law.
18. Does the regulation provide any exemptions or alternative means of compliance for small businesses? Please explain. No, all food processing establishments must comply with the rule to ensure they are producing safe food.
*ORC does not allow ODA to regulate or license businesses regulated by the Div. of Liquor Control. If performing the regulating function in a contract for FDA it may be OK if language is inserted to specify only for FDA Contract inspections.
I sent below ORC sections before, please read:
The licensing and regulation in Ohio by the Food Safety Div are in violation of Ohio codes. We are licensed and regulated for all production and sales activity by the Federal government Alcohol &To***co Tax & Trade Bureau (TTB) and the Ohio Div of Liquor Control. Under federal codes CFR 27 we are more regulated for what we can use to make wine than any regular food product. Any exceptions like a vegetative wine like mint or dandelion or additions of spices have to go through a formula approval process. Nothing like in the food regulation world by the FDA. On the state level of "food processing establishment" here is the relevant code:
*ORC3715.021 Standards and good manufacturing practices for food processing establishments.
(A) As used in this section, "food processing establishment" means a premises or part of a premises where food is processed, packaged, manufactured, or otherwise held or handled for distribution to another location or for sale at wholesale. "Food processing establishment" includes the activities of a bakery, confectionery, cannery, bottler, warehouse, or distributor, and the activities of an entity that receives or salvages distressed food for sale or use as food. A "food processing establishment" does not include a cottage food production operation; a processor of tree syrup who boils sap when a minimum of seventy-five per cent of the sap used to produce the syrup is collected directly from trees by that processor; a processor of sorghum who processes sorghum juice when a minimum of seventy-five per cent of the sorghum juice used to produce the sorghum is extracted directly from sorghum plants by that processor; a beekeeper who jars honey when a minimum of seventy-five per cent of the honey is from that beekeeper's own hives; or a processor of apple syrup or apple butter who directly harvests from trees a minimum of seventy-five per cent of the apples used to produce the apple syrup or apple butter.
{B} The director of agriculture shall adopt rules in accordance with Chapter 119. of the Revised Code that establish, when otherwise not established by the Revised Code, standards and good manufacturing practices for food processing establishments, including the facilities of food processing establishments and their sanitation. The rules shall conform with or be equivalent to the standards for foods established by the United States food and drug administration in Title 21 of the Code of Federal Regulations.
Note the exception in Section {B}, "when otherwise not established by the Revised Code." This which it seems can only apply to alcoholic beverages, is otherwise established in Title 43 of the ORC::
*ORC4301.10 Division of liquor control powers and duties.
(A) The division of liquor control shall do all of the following:
(1) Control the traffic in beer and intoxicating liquor in this state, including the manufacture, importation, and sale of beer and intoxicating liquor;
*ORC4301.01 Liquor control definitions.
(A) As used in the Revised Code:
(1) "Intoxicating liquor" and "liquor" include all liquids and compounds, other than beer, containing one-half of one per cent or more of alcohol by volume which are fit to use for beverage purposes, from whatever source and by whatever process produced, by whatever name called, and whether they are medicated, proprietary, or patented. "Intoxicating liquor" and "liquor" include cider and alcohol, and all solids and confections which contain one-half of one per cent or more of alcohol by volume.
{8} "Manufacture" includes all processes by which beer or intoxicating liquor is produced, whether by distillation, rectifying, fortifying, blending, fermentation, or brewing, or in any other manner.
On the Federal level the FAA (Federal Alcohol Administration Act) cedes authority for wine under 7% to the FDA. But, in Ohio the Revised code says any over 1/2% shall be controlled by the Division of Liquor Control not the ODA.
Also, the duplicate licensing (and fees) has similar language, and as well as the duplicate regulation needs to be eliminated. ORC 3715.02 (A) The director of agriculture shall adopt rules in accordance with Chapter 119. of the Revised Code that establish, when otherwise not established by a law of this state, definitions for a food or class of food and standards for the following items as they pertain to the food or class of food:
This does not support the duplicate licensing fees neither as the intoxicating beverages are otherwise established by law in Ohio. As I read it ODA should have no regulatory nor licensing authority over producers or distributors of alcoholic beverages in Ohio of "any kind". The ORC gives total authority in Title 43 which definitely looks exclusionary to ODA being able to license or regulate alcoholic beverage businesses. As for the ODA contracts to inspect FDA registered wineries and others that is something to be worked out. FDA currently has that power, which I object to, but they do have exclusions for small business and businesses that retail in dollars more than they wholesale. Maybe some language like "including processors of intoxicating beverages registered with the FDA for contract inspections only" could be used?
The laws have been established to eliminate this kind of duplicate licensing and regulation in Ohio and I fail to see why you are continuing in this OAC Chapter 901:3-17 and 901:3-18-01 and 901:3-24-01 to perpetuate a system of duplicate regulation as well as licensing in 901:3-21-01. The only remedy I see it to substitute language that clarifies these are for FDA Contract inspections only, whether its production, shipping or any other aspect. Having language that violates the intent of the ORC passed legislation should be eliminated and ODA regulation and registration (licensing) of businesses not subject to FDA contract inspections should be eliminated. ODA is controlling the licensing, traffic, manufacture and sale of intoxicating beverages in Ohio in duplication and violating the ORC sections mentioned and others.
